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Short-lasting pediatric laparoscopic surgery: Are muscle relaxants necessary? Endotracheal intubation vs. laryngeal mask airway
Journal of Pediatric Surgery 52 (2017) 1705–1710
Contents lists available at ScienceDirect
Journal of Pediatric Surgery journal homepage: www.elsevier.com/locate/jpedsurg
Prospective Clinical Trial
Short-lasting pediatric laparoscopic surgery: Are muscle relaxants necessary? Endotracheal intubation vs. laryngeal mask airway Serkan Tulgar a, Ibrahim Boga b, Basri Cakiroglu c, David Terence Thomas d,⁎ a
Maltepe University Faculty of Medicine, Department of Anesthesiology & Reanimation, Istanbul, Turkey Pendik State Hospital, Department of Anesthesiology & Reanimation, Istanbul,Turkey Hisar Intercontinental Hospital, Department of Urology, Istanbul, Turkey d Maltepe University Faculty of Medicine, Department of Pediatric Surgery, Istanbul, Turkey b c
a r t i c l e
i n f o
Article history: Received 6 November 2016 Received in revised form 16 January 2017 Accepted 7 February 2017 Key words: Laparoscopy Pediatric Muscle relaxant
a b s t r a c t Purpose: Technical advances have led to lower insufflation pressures and shorter anesthesia times for children undergoing laparoscopic procedures. In this study we compared the use of endotracheal tube (ETT) and laryngeal mask airway (LMA) with or without muscle relaxant (MR) in children undergoing laparoscopic repair for inguinal hernia. Methods: Children undergoing laparoscopic inguinal hernia repair were randomized into four groups which underwent procedure with either ETT + MR (group 1), ETT without MR (group 2), LMA with subparalytic dose of MR (group 3) or LMA without MR (group 4). Surgical, anesthesia and recovery times, intragastric pressures and peak airway pressures during insufflation were compared. Results: After exclusion criteria and discontinued interventions, groups 1 and 3 contained 20, groups 2 and 4 contained 19 patients each. Surgical times were similar between groups. Anesthesia times were statistically significantly different between groups with shortest time in group 4 and longest time in group 1. Recovery time was statistically significantly longer in group 1 when compared to other groups. There was no difference between basal intragastric pressure, average intragastric pressure during insufflation, peak airway pressure, and average peak airway pressure during insufflation of groups. Conclusion: Use of muscle relaxants in short-lasting laparoscopic procedures in children is not absolutely necessary and LMA with subparalytic dose of muscle relaxant or with no muscle relaxant is a safe alternative. Type of study: Treatment study. Level of evidence: Level II. © 2017 Elsevier Inc. All rights reserved.
Inguinal hernia is one of the most frequent indications for surgery in children, and its minimal invasive repair has recently gained popularity [1–4]. Inguinal hernia repair is performed under general anesthesia. While both endotracheal intubation (ETT) and laryngeal mask airway (LMA) devices can be used as airway management devices during conventional pediatric inguinal hernia repair, ETT is generally preferred when laparoscopic hernia repair is performed. Although there are reports in literature of the safe use of laryngeal mask airway (LMA) in pediatric laparoscopic surgery [5–7], its use has not gained popularity [8]. For more than 30 years, Laryngeal Mask Airway-Classic™ (C-LMA) has been used in adults and children for short-lasting surgical procedures where the patient is in the supine position. New LMA models have been developed and their use has been increasing [5,9]. Developed in 2000, LMA-Proseal™ (P-LMA) also provides gastric access while LMA is in situ [10,11]. However, ETT is still the gold standard, especially in
patients who have a high risk of aspiration of gastric contents, such as those with a full stomach or with gastric motility problems [12]. Recently, more minimally invasive laparoscopic techniques for the repair of pediatric inguinal hernia with surgical times of 15–20 min have been reported [2,4]. Low insufflation pressures and shorter anesthesia times have led to a review of the need for ETT and muscle relaxants in these patients. This study aimed to answer two research questions: a) can P-LMA be safely used in short-lasting pediatric laparoscopic surgery; b) is the use of muscle relaxants absolutely necessary in these procedures? In order to answer these questions, we compared the use of ETT and P-LMA with or without muscle relaxants in patients undergoing laparoscopic repair for inguinal hernia. Comparison was performed by analyzing surgical times, anesthesia times and pressure variables, with the null hypothesis that there was no difference between combinations. 1. Material & methods
⁎ Corresponding author at: Maltepe University Faculty of Medicine, Departments of Pediatric Surgery & Medical Education, Feyzullah Caddesi No. 39, Maltepe, Istanbul, Turkey. E-mail address: [email protected] (D.T. Thomas). http://dx.doi.org/10.1016/j.jpedsurg.2017.02.010 0022-3468/© 2017 Elsevier Inc. All rights reserved.
This blinded, prospective, randomized safety control study was performed after local ethics committee approval and in accordance with
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the principles outlined in the Declaration of Helsinki. The study was registered with clinicaltrials.gov (Registration No: NCT02696837) and CONSORT checklist was used for enrollment and allocation of patients. (Fig. 1) Recruitment was performed between March 2016 and May 2016 and surgical procedures took place between March 2016 and June 2016. All parents gave written informed consent for participation of their children in this study. Patients aged between 0 and 12 years and b30 kg who were due to undergo laparoscopic repair for single-sided inguinal hernia or communicating hydrocele were recruited. Those with previous abdominal surgery and/or comorbidities that would affect surgical time, time under anesthesia, intragastric pressure (IGP) and abdominal pressure were excluded from the study. 1.1. Anesthesia technique & groups Using the closed envelope method, patients were randomized into four possible groups on the morning of surgery. Closed envelope was chosen by a ward nurse. The randomization process and its records were conducted under the supervision of a single author (DTT). Each group consisted of 20 patients. All patients received 0.5 mg/kg of oral midazolam 1 h before surgery. In the operating room, IV access was inserted, patients were routinely monitored and preoxygenation was administered. Group 1: In this group, patients underwent ETT with a muscle relaxant. First, 0.5-mg/kg lidocaine (Aritmal %2, Osel Ilaç, Turkey) was intravenously administered. Subsequently, 1-mcg/kg fentanyl (Talinat 0.1 mg/ 2 mL, VEM İlaç, Turkey), 2.5-mg/kg propofol (Pofol IV ampul 10 mg/mL, Sandoz Ilaç, Turkey) was administered. Lastly, 0.6mg/kg rocuronium (Esmeron 10 mg/mL, Merck Sharp Dohme İlaç, Turkey) was administered and ETT intubation performed. Group 2: In this group, patients underwent ETT without a muscle relaxant. After 0.5 mg/kg of lidocaine, remifentanil (Ultiva 2 mg, Glaxosmithkline İlaç, Turkey) 2 μg/kg (bolus in 30–60 s) and 2.5-mg/kg propofol were administered. After depth of anesthesia was achieved, ETT intubation was performed. Group 3: In this group, patients underwent surgery with P-LMA using a subparalytic dose of nondepolarizing muscle relaxant. Following 0.5-mg/kg lidocaine, 1-mcg/kg fentanyl, 2.5-mg/kg propofol and 0.2-mg/kg rocuronium was respectively administered and appropriate P-LMA according to age and weight was placed. Group 4: In this group, patients underwent surgery with P-LMA with no muscle relaxant. Following 0.5-mg/kg lidocaine, 1-mcg/kg fentanyl and 2.5-mg/kg propofol were administered and appropriate P-LMA according to age and weight was placed. Anesthesia was maintained using inhalation of 2% sevoflurane. Ventilation parameters were set as tidal volume of 10 ml/kg and respiratory rate of 15 per minute. Respiratory rate was adjusted perioperatively according to the patients' EtCO2. Fresh gas flow was set at 3 lt/m. In groups 1 and 3 where muscle relaxants were used, the effect of muscle relaxant was reversed using atropine 0.02 mg/kg and neostigmine 0.04 mg/kg that was administered when patients were observed to swallow. ETT was chosen using the formula age/4 + 4.5. All ETT were uncuffed. P-LMA was chosen according to reference written on the products manual. Following ETT or P-LMA placement, bilateral lung auscultation was performed and ventilation was confirmed using a capnograph. Epigastric auscultation was performed to determine air leakage. When air leakage was detected, P-LMA was reintroduced. Patients with air leakage following two placements were intubated and excluded from the study. For patients with air leakage after ETT, patients were re-intubated using a 0.5 larger size tube. Patients who had air
leakage after second intubation and patients with 2 or more failed intubation attempts were excluded from the study as peri and postoperative outcome measures may be effected.
1.2. Patient monitoring All patients underwent monitoring using electrocardiography, pulse oximetry, non-invasive blood pressure monitoring, capnography and EtCO2. Following induction, 8–14-Fr tube was placed orogastrically. Gastric content and air were aspirated and the orogastric tube was removed. P-LMA or ETT was placed immediately after this aspiration. Following intubation or P-LMA placement, a 8–14-Fr tube was attached to the pressure transducer using a three way stopcock. The nasogastric tube was filled with sterile saline and pressure transducer was zeroed. The nasogastric tube was lubricated and in groups 1 and 2 placed orogastrically and in groups 3 and 4 placed through the P-LMA's drainage port. Pressure measurements were made using the anterior axillary line at the level of the xiphoid process as a reference point. Pressure measurements were made using the hydrostatic pressure measurement technique reported previously [5].
1.3. Surgical technique Inguinal hernia repair was performed in the supine position, using the PIRS (percutaneous internal ring suturing) technique in all patients, as previously described [2]. Insufflation pressure was set at 8 cmH2O for all patients.
1.4. Intraoperative measurements Following skin preparation and sterile draping of patient, EtCO2, IGP, insufflation pressure, SpO2, HR, and Ppeak were measured at 0th minute (basal) and every minute while the surgical procedure lasted. Insufflation pressure was monitored from the laparoscopy device. All other measurements were recorded from the anesthesia device. Surgical time was defined as time from beginning of skin preparation to completion of umbilical and inguinal wound dressing. Anesthesia time was defined as time from induction to removal of airway device. Recovery time was defined as time from removal of airway device to modified Aldrete score of 9 or above. Events such as aspiration, vomiting, laryngospasm, movement or muscle contraction, response to surgical stimulus, swallowing etc. were noted. Patients were followed for any complications during awakening, recovery and for 2–6 h postoperatively. All patients received 10-mg/kg IV paracetamol preoperatively as well as local anesthetic injection to port site. Patients were taken to recovery room after adequate respiratory effort was observed. Patient was transferred to the ward when the modified Aldrete score was 9 or above, and time was noted. Recovery room and ward staff were blinded to the group of the patients.
1.5. Outcome measures During the design phase of the study, primary outcome measures were planned as intragastric pressure, P-peak and insufflation pressures and their relationship and secondary outcome measures were planned as time under anesthesia, surgical time and perioperative or postoperative anesthesia-related problems. Methods used when the detailed anesthesia regimes were used or when patients responded to surgical stimuli, the effect of additional drugs on anesthesia and surgical times were later added as secondary measures. Sample size was determined by authors using data from previous studies [5,13,14].
S. Tulgar et al. / Journal of Pediatric Surgery 52 (2017) 1705–1710
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Fig. 1. CONSORT flow diagram.
1.6. Statistical analysis All analysis was performed by two authors (IB and BC) who were both blinded. SPSS 16.0 Statistical package programme (SPSS, Chicago, IL, USA) was used for statistical analysis. Variables were evaluated for normal distribution using the Kolmogorov–Smirnov test. Mean ± standard deviation was used for descriptive statistics. Ratios were compared using chi square. Continuous variables were compared using one way ANOVA with post hoc Tukey analysis. A p-value of b 0.05 was considered statistically significant. 2. Results Each group consisted of 20 patients. In order to reach 80 patients, 94 patients were assessed for eligibility. Of these patients 12 did not meet inclusion criteria or met exclusion criteria and 2 patients' parents refused to participate in the study. No patient in groups 1 or 2 were difficult intubation or ventilation. One patient in group 2 was found to have bilateral patient processus vaginalis and was excluded from the study. One patient in group 4 had persistent air leakage despite reintroduction of P-LMA and therefore required intubation and was excluded from the study. Therefore groups 2 and 4 had 19 and groups 1 and 3 had 20 patients at final analysis. CONSORT flowchart is shown in Fig. 1.
Demographic information (age, sex and weight) are shown in Table 1. There was no statistical difference between groups with regard to demographic data. Anesthesia time, surgical time and recovery time averages for each group are shown in Table 2. Average surgical time was longest in group 4 (15.1 m) and shortest in group 1 (13.6 m). There was no statistical difference between the average surgical times between groups. The shortest and longest average anesthesia time was observed in group 4 and group 1, respectively (26.4 m vs. 37.1 m). There was a statistically significant difference between the average anesthesia times between groups (p b 0.001). There was a statistically significant difference between group 1 vs. group 2 (p = 0.023), group 1 vs. group 3 (p b 0.001) and group 1 vs. group 4 (p b 0.001). There was no statistically significant difference between group 2 vs. group 3 (p = 0.510), group 2 vs. group 4 (p = 0.09) and group 3 vs. group 4 (p = 0.754). The shortest and longest average recovery time was also observed in group 4 and group 1 respectively (7.5 m vs. 14.5 m) and recovery time were observed in group 4 and group 1, respectively. There was a statistically significant difference between groups 1–3, groups 1–4, groups 2–3 and groups 2–4 (p b 0.001, p b 0.001, p = 0.002 and p b 0.001 respectively). No statistically significant difference was found between group 1 vs. group 2 (p = 0.948) or group 3 vs. group 4 (p = 0.471). Intragastric pressure and peak airway pressure (Ppeak) for each group are shown in Table 3. Box plot of basal intragastric pressure,
Table 1 Demographic information, *: one way ANOVA, **: chi square.
Age (y) 1 Sex (M/F) Weight (kg)
Group 1 (n = 20)
Group 2 (n = 19)
Group 3 (n = 20)
Group 4 (n = 19)
p
5.1 ± 1.8 13/7 18.5 ± 5.6
4.9 ± 0.9 12/7 16.3 ± 4.6
5.3 ± 1.5 14/6 20.2 ± 6.3
5.5 ± 1.9 12/7 17.5 ± 6.6
0.675* 0.965** 0.205*
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Table 2 Comparison of anesthesia time, surgical time and recovery time between groups. * ANOVA with post hoc Tukey analysis.
Anesthesia time Surgical time Recovery time
Group 1 (n = 20)
Group 2 (n = 19)
Group 3 (n = 20)
Group 4 (n = 19)
p
37.1 ± 5.6 13.6 ± 2.7 14.5 ± 4.0
31.2 ± 7.2 13.8 ± 2.4 13.9 ± 3.4
28.4 ± 5.8 14.3 ± 1.9 9.1 ± 2.6
26.4 ± 6.1 15.1 ± 3.6 7.5 ± 3.6
b0.001 0.345 b0.001
Table 3 Comparison of intragastric pressure (IGP) and peak airway pressure (Ppeak), *: ANOVA. Group 1 (n = 20) Basal IGP Average IGP during insufflation Basal Ppeak Average Ppeak during insufflation
Group 2 (n = 19)
Group 3 (n = 20)
Group 4 (n = 19)
p
10.7 ± 2.2 11.3 ± 2.2 11.3 ± 2.8 11.6 ± 1.7 0.579* 13.8 ± 2.5 14.1 ± 2.8 15.9 ± 2.9 15.7 ± 3.3 0.053* 14.8 ± 2.3 14.2 ± 2.1 15.3 ± 2.0 15.9 ± 2.2 0.087* 15.4 ± 2.6 15.5 ± 2.3 16.6 ± 2.4 17.0 ± 2.9 0.132*
There was no response to umbilical incision in groups 1, 2 or 3. In group 4, 7 patients were observed to respond to incision. All 7 patients were administered a single dose of 1 mg/kg intravenous propofol and surgeries were completed thereafter. No perioperative complications were observed. During the postoperative period, one patient in group 1 had coughing and one patient in groups 2, 3 and 4 respectively complained of a sore throat. No additional anesthesia was required in any patient.
3. Discussion
average intragastric pressure during insufflation, average basal Ppeak and average Ppeak during insufflation is shown in Fig. 2. There was no statistically significant difference between groups with regard to basal intragastric pressure, average intragastric pressure during insufflation, basal Ppeak and average Ppeak during insufflation. Basal intragastric pressure was higher in group 4 when compared to other groups, but the difference was not statistically significant. No patients' intragastric pressure was observed to pass 20 cmH2O. Ppeak was found to increase in correlation with IGP. No significant change in SpO2 or EtCO2 was observed during insufflation for any groups. All patients' insufflation pressure was set and remained at 8 cmH2O during the procedure, giving adequate surgical field view.
Our data have shown that, similar to ETT intubation, P-LMA is safe in children undergoing short-lasting surgical procedures such as inguinal hernia or communicating hydrocele repair using PIRS technique. In children undergoing short-lasting surgical procedures with low insufflation pressures, safe anesthesia management can be obtained using P-LMA with no muscle relaxant or with subparalytic doses. Endotracheal intubation is considered to be safer when compared to LMA in general anesthesia practices. However, LMA is reported to be safely used in all age groups for various surgical procedures [15,16]. Anesthesiologist avoided the use of LMA for laparoscopic procedures because of the fear of airway safety issues secondary to abdominal insufflation [8]. The use of muscle relaxants in laparoscopic surgery offer increased visibility of the surgical field and decrease the risk of
Fig. 2. Box plot for basal intragastric pressure (A), average intragastric pressure during insufflation (B), basal peak airway pressure (C), and average peak airway perssure during insufflation (D) of groups showing minimum, first quartile, median, third quartile and maximum pressures.
S. Tulgar et al. / Journal of Pediatric Surgery 52 (2017) 1705–1710
complications because of patient movement while trocars or laparoscopic hand tools are in place. However, the use of muscle relaxants are associated with increased mortality and anesthesia-related complications [17]. Recently studies have been reporting the safety of LMA use in both adults and children [7,8,18]. In adult patients, the use of LMA has been reported in patients undergoing laparoscopic cholecystectomy and laparoscopic gynecological procedures. It is important to note that one study of laparoscopic gynecological procedures reported the use of subparalytic doses of muscle relaxants with LMA [19], as has several studies of LMA use in laparoscopic cholecystectomy procedures [9,20,21]. Chen et al. [22] investigated the requirement of muscle relaxants for laparoscopic gynecological procedures performed with P-LMA. All patients underwent surgery using P-LMA and the authors reported no difference in patient satisfaction, surgical time and recovery time between patients who underwent the procedure with or without muscle relaxant. In patients undergoing a surgical procedure using LMA, the effect of abdominal insufflation on gastric distention and ventilation has been a topic of interest and several studies using different types of LMA have been performed [5,9,23]. Gastric distention negatively effects the field of view in upper gastrointestinal surgery such as laparoscopic cholecystectomy. Gastric distention is a subjective criteria and therefore the measurement of intragastric pressure is more valuable. One study reported that intraabdominal pressure as measured using an intravesical catheter, significantly correlated with intragastric pressure measurements [24]. While the evidence on the relationship between intragastic pressure and intraabdominal pressure in children is conflicting, intragastric pressure is commonly used as it is a simple and noninvasive technique to reflect intraabdominal pressure [25]. High intraabdominal and therefore intragastric pressures may lead to the regurgitation and aspiration of gastric contents in patients with LMA, with potential fatal consequences. Our study demonstrated that under low insufflation pressures, intragastric pressure was only minimally affected. Ozdamar et al. [5] compared ventilation parameters and intragastric pressures in children undergoing laparoscopic procedures with ETT and LMA, and reported that LMA is a safe alternative to ETT. In their study, vecuronium (0.08 mg/kg) - a steroid-structured non-depolarising muscle relaxant was used for ETT and LMA. Average insufflation times were over 50 min. However, many pediatric laparoscopic procedures last shorter nowadays. The PIRS procedure we used in this study lasts between 15 and 20 min and therefore the use of long-acting muscle relaxant was not necessary in either the ETT or LMA groups. Miranov et al. [6] concluded that classical LMA can be used in shortlasting pediatric laparoscopic surgery in patients without respiratory disease. They reported that LMA decreased awakening time. However, the average surgical time was 50 min. In this study, patients underwent a relatively short laparoscopic procedure where low insufflation pressures are adequate for good view of surgical field. Intubation with remifentanil may also be an alternative as was performed in group 2. However, both subparalytic doses of rocuronium with P-LMA and P-LMA without muscle relaxant are both safe alternative methods. Both these methods lead to shorter time under anesthesia and faster recovery times. Our study has several limitations. Because of a pediatric population of differing ages, we were unable to evaluate some postoperative complications such as sore throat. We measured intragastric pressures but did not have any method of confirming the location of the tube. A tube misplaced in the esophagus or duodenum would have given misleading results. Ultrasonography to confirm the location of the nasogastric tube would have been useful. The choice of drug and dosage difference at induction was different for all groups. This can be considered as a limitation. However, our aim was not to compare the effect of different drugs on anesthesia or surgical time, but to compare four different combination of drugs and airway devices. We could have used pH monitoring, especially in patients where LMA was used, in order to evaluate any micro-aspirations.
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It must be noted that, our study population is of a very specific group of patients, with an average age of 5.2 years using an insufflation pressure of 8 mmH2O in surgeries lasting around 15 min. We observed four patients with anesthesia-related complications. Although we determined our sample size according to previous studies, anesthesiarelated complications are rare and would require a larger sample size to accurately determine. Our data may not be generalisable to the whole pediatric population. However, we believe that this study will form a basis for further research. In conclusion, the use of muscle relaxants in short-lasting laparoscopic procedures in children is not absolutely necessary and LMA with subparalytic dose of muscle relaxant or with no muscle relaxant is a safe alternative, although this may not be generalisable for all pediatric age groups or procedures. Conflict of interest The authors have no conflict of interest to declare. Funding The authors received no funding for this study. References [1] Chang S-J, Chen JY-C, Hsu C-K, et al. The incidence of inguinal hernia and associated risk factors of incarceration in pediatric inguinal hernia: a nation-wide longitudinal population-based study. Hernia 2015. http://dx.doi.org/10.1007/s10029-015-1450-x. [2] Thomas DT, Göcmen KB, Tulgar S, et al. Percutaneous internal ring suturing is a safe and effective method for the minimal invasive treatment of pediatric inguinal hernia: experience with 250 cases. J Pediatr Surg 2016;51(8):1330–5. [3] Li S, Li M, Wong KKY, et al. Laparoscopically assisted simple suturing obliteration (LASSO) of the internal ring using an epidural needle: a handy single-port laparoscopic herniorrhaphy in children. J Pediatr Surg 2014;49:1818–20. [4] McClain L, Streck C, Lesher A, et al. Laparoscopic needle-assisted inguinal hernia repair in 495 children. Surg Endosc 2015;29:781–6. [5] Ozdamar D, Güvenç BH, Toker K, et al. Comparison of the effect of LMA and ETT on ventilation and intragastric pressure in pediatric laparoscopic procedures. Minerva Anestesiol 2010;76:592–9. [6] Mironov PI, Estekhin AM, Mirasov AA. Anaesthetic maintenance with laryngeal mask for a laparoscopic surgery in pediatric patients. Anesteziol Reanimatol 2013: 10–4. [7] Sinha A, Sharma B, Sood J. ProSeal as an alternative to endotracheal intubation in pediatric laparoscopy. Paediatr Anaesth 2007;17:327–32. [8] Patel A, Clark SR, Schiffmiller M, et al. A survey of practice patterns in the use of laryngeal mask by pediatric anesthesiologists. Paediatr Anaesth 2015;25:1127–31. [9] Cha SM, Park S, Kang H, et al. Gastric distension with SLIPA versus LMA ProSeal during laparoscopic cholecystectomy: a randomized trial. Surg Laparosc Endosc Percutan Tech 2014;24:216–20. [10] Brain AIJ, Verghese C, Strube PJ. The LMA “ProSeal”—a laryngeal mask with an oesophageal vent. Br J Anaesth 2000;84:650–4. [11] Sharma V, Verghese C, McKenna PJ. Prospective audit on the use of the LMASupreme TM for airway management of adult patients undergoing elective orthopaedic surgery in prone position. Br J Anaesth 2010;105:228–32. [12] Aydogmus MT, Turk HSY, Oba S, et al. Can SupremeTM laryngeal mask airway be an alternative to endotracheal intubation in laparoscopic surgery? Braz J Anesthesiol 2014;64:66–70. [13] Engum SA, Kogon B, Jensen E, et al. Gastric tonometry and direct intraabdominal pressure monitoring in abdominal compartment syndrome. J Pediatr Surg 2002; 37:214–8. [14] Moragas G, Azpiroz F, Pavia J, et al. Relations among intragastric pressure, postcibal perception, and gastric emptying. Am J Physiol 1993;264:G1112–7. [15] Sanket B, Ramavakoda CY, Nishtala MR, et al. Comparison of second-generation supraglottic airway devices (i-gel versus LMA ProSeal) during elective surgery in children. AANA J 2015;83:275–80. [16] Yao T, Yang X-L, Zhang F, et al. The feasibility of supreme laryngeal mask airway in gynecological laparoscopy surgery. Zhonghua Yi Xue Za Zhi 2010;90:2048–51. [17] Ledowski T. Muscle relaxation in laparoscopic surgery: what is the evidence for improved operating conditions and patient outcome? A brief review of the literature. Surg Laparosc Endosc Percutan Tech 2015;25:281–5. [18] Timmermann A, Bergner UA, Russo SG. Laryngeal mask airway indications: new frontiers for second-generation supraglottic airways. Curr Opin Anaesthesiol 2015; 28:717–26. [19] Griffiths JD, Nguyen M, Lau H, et al. A prospective randomised comparison of the LMA ProSeal (TM) versus endotracheal tube on the severity of postoperative pain following gynaecological laparoscopy. Anaesth Intensive Care 2013;41:46.
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[20] Jeon WJ, Cho SY, Baek SJ, et al. Comparison of the Proseal LMA and intersurgical I-gel during gynecological laparoscopy. Korean J Anesthesiol 2012;63:510–4. [21] Saraswat N, Kumar A, Mishra A, et al. The comparison of Proseal laryngeal mask airway and endotracheal tube in patients undergoing laparoscopic surgeries under general anaesthesia. Indian J Anaesth 2011;55:129–34. [22] Chen B-Z, Ben-zhen C, Ling T, et al. Is muscle relaxant necessary in patients undergoing laparoscopic gynecological surgery with a ProSeal LMATM? J Clin Anesth 2013; 25:32–5.
[23] Maltby JR, Beriault MT, Watson NC, et al. Gastric distension and ventilation during laparoscopic cholecystectomy: LMA-classic vs. tracheal intubation. Can J Anaesth 2000;47:622–6. [24] Iqbal A, Haider M, Stadlhuber RJ, et al. A study of intragastric and intravesicular pressure changes during rest, coughing, weight lifting, retching, and vomiting. Surg Endosc 2008;22:2571–5. [25] Mandal KC, Halder P, Barman S, et al. Intragastric pressure: useful indicator in the management of congenital diaphragmatic hernia. J Indian Assoc Pediatr Surg 2016;21(4):175–7.
Contents lists available at ScienceDirect
Journal of Pediatric Surgery journal homepage: www.elsevier.com/locate/jpedsurg
Prospective Clinical Trial
Short-lasting pediatric laparoscopic surgery: Are muscle relaxants necessary? Endotracheal intubation vs. laryngeal mask airway Serkan Tulgar a, Ibrahim Boga b, Basri Cakiroglu c, David Terence Thomas d,⁎ a
Maltepe University Faculty of Medicine, Department of Anesthesiology & Reanimation, Istanbul, Turkey Pendik State Hospital, Department of Anesthesiology & Reanimation, Istanbul,Turkey Hisar Intercontinental Hospital, Department of Urology, Istanbul, Turkey d Maltepe University Faculty of Medicine, Department of Pediatric Surgery, Istanbul, Turkey b c
a r t i c l e
i n f o
Article history: Received 6 November 2016 Received in revised form 16 January 2017 Accepted 7 February 2017 Key words: Laparoscopy Pediatric Muscle relaxant
a b s t r a c t Purpose: Technical advances have led to lower insufflation pressures and shorter anesthesia times for children undergoing laparoscopic procedures. In this study we compared the use of endotracheal tube (ETT) and laryngeal mask airway (LMA) with or without muscle relaxant (MR) in children undergoing laparoscopic repair for inguinal hernia. Methods: Children undergoing laparoscopic inguinal hernia repair were randomized into four groups which underwent procedure with either ETT + MR (group 1), ETT without MR (group 2), LMA with subparalytic dose of MR (group 3) or LMA without MR (group 4). Surgical, anesthesia and recovery times, intragastric pressures and peak airway pressures during insufflation were compared. Results: After exclusion criteria and discontinued interventions, groups 1 and 3 contained 20, groups 2 and 4 contained 19 patients each. Surgical times were similar between groups. Anesthesia times were statistically significantly different between groups with shortest time in group 4 and longest time in group 1. Recovery time was statistically significantly longer in group 1 when compared to other groups. There was no difference between basal intragastric pressure, average intragastric pressure during insufflation, peak airway pressure, and average peak airway pressure during insufflation of groups. Conclusion: Use of muscle relaxants in short-lasting laparoscopic procedures in children is not absolutely necessary and LMA with subparalytic dose of muscle relaxant or with no muscle relaxant is a safe alternative. Type of study: Treatment study. Level of evidence: Level II. © 2017 Elsevier Inc. All rights reserved.
Inguinal hernia is one of the most frequent indications for surgery in children, and its minimal invasive repair has recently gained popularity [1–4]. Inguinal hernia repair is performed under general anesthesia. While both endotracheal intubation (ETT) and laryngeal mask airway (LMA) devices can be used as airway management devices during conventional pediatric inguinal hernia repair, ETT is generally preferred when laparoscopic hernia repair is performed. Although there are reports in literature of the safe use of laryngeal mask airway (LMA) in pediatric laparoscopic surgery [5–7], its use has not gained popularity [8]. For more than 30 years, Laryngeal Mask Airway-Classic™ (C-LMA) has been used in adults and children for short-lasting surgical procedures where the patient is in the supine position. New LMA models have been developed and their use has been increasing [5,9]. Developed in 2000, LMA-Proseal™ (P-LMA) also provides gastric access while LMA is in situ [10,11]. However, ETT is still the gold standard, especially in
patients who have a high risk of aspiration of gastric contents, such as those with a full stomach or with gastric motility problems [12]. Recently, more minimally invasive laparoscopic techniques for the repair of pediatric inguinal hernia with surgical times of 15–20 min have been reported [2,4]. Low insufflation pressures and shorter anesthesia times have led to a review of the need for ETT and muscle relaxants in these patients. This study aimed to answer two research questions: a) can P-LMA be safely used in short-lasting pediatric laparoscopic surgery; b) is the use of muscle relaxants absolutely necessary in these procedures? In order to answer these questions, we compared the use of ETT and P-LMA with or without muscle relaxants in patients undergoing laparoscopic repair for inguinal hernia. Comparison was performed by analyzing surgical times, anesthesia times and pressure variables, with the null hypothesis that there was no difference between combinations. 1. Material & methods
⁎ Corresponding author at: Maltepe University Faculty of Medicine, Departments of Pediatric Surgery & Medical Education, Feyzullah Caddesi No. 39, Maltepe, Istanbul, Turkey. E-mail address: [email protected] (D.T. Thomas). http://dx.doi.org/10.1016/j.jpedsurg.2017.02.010 0022-3468/© 2017 Elsevier Inc. All rights reserved.
This blinded, prospective, randomized safety control study was performed after local ethics committee approval and in accordance with
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the principles outlined in the Declaration of Helsinki. The study was registered with clinicaltrials.gov (Registration No: NCT02696837) and CONSORT checklist was used for enrollment and allocation of patients. (Fig. 1) Recruitment was performed between March 2016 and May 2016 and surgical procedures took place between March 2016 and June 2016. All parents gave written informed consent for participation of their children in this study. Patients aged between 0 and 12 years and b30 kg who were due to undergo laparoscopic repair for single-sided inguinal hernia or communicating hydrocele were recruited. Those with previous abdominal surgery and/or comorbidities that would affect surgical time, time under anesthesia, intragastric pressure (IGP) and abdominal pressure were excluded from the study. 1.1. Anesthesia technique & groups Using the closed envelope method, patients were randomized into four possible groups on the morning of surgery. Closed envelope was chosen by a ward nurse. The randomization process and its records were conducted under the supervision of a single author (DTT). Each group consisted of 20 patients. All patients received 0.5 mg/kg of oral midazolam 1 h before surgery. In the operating room, IV access was inserted, patients were routinely monitored and preoxygenation was administered. Group 1: In this group, patients underwent ETT with a muscle relaxant. First, 0.5-mg/kg lidocaine (Aritmal %2, Osel Ilaç, Turkey) was intravenously administered. Subsequently, 1-mcg/kg fentanyl (Talinat 0.1 mg/ 2 mL, VEM İlaç, Turkey), 2.5-mg/kg propofol (Pofol IV ampul 10 mg/mL, Sandoz Ilaç, Turkey) was administered. Lastly, 0.6mg/kg rocuronium (Esmeron 10 mg/mL, Merck Sharp Dohme İlaç, Turkey) was administered and ETT intubation performed. Group 2: In this group, patients underwent ETT without a muscle relaxant. After 0.5 mg/kg of lidocaine, remifentanil (Ultiva 2 mg, Glaxosmithkline İlaç, Turkey) 2 μg/kg (bolus in 30–60 s) and 2.5-mg/kg propofol were administered. After depth of anesthesia was achieved, ETT intubation was performed. Group 3: In this group, patients underwent surgery with P-LMA using a subparalytic dose of nondepolarizing muscle relaxant. Following 0.5-mg/kg lidocaine, 1-mcg/kg fentanyl, 2.5-mg/kg propofol and 0.2-mg/kg rocuronium was respectively administered and appropriate P-LMA according to age and weight was placed. Group 4: In this group, patients underwent surgery with P-LMA with no muscle relaxant. Following 0.5-mg/kg lidocaine, 1-mcg/kg fentanyl and 2.5-mg/kg propofol were administered and appropriate P-LMA according to age and weight was placed. Anesthesia was maintained using inhalation of 2% sevoflurane. Ventilation parameters were set as tidal volume of 10 ml/kg and respiratory rate of 15 per minute. Respiratory rate was adjusted perioperatively according to the patients' EtCO2. Fresh gas flow was set at 3 lt/m. In groups 1 and 3 where muscle relaxants were used, the effect of muscle relaxant was reversed using atropine 0.02 mg/kg and neostigmine 0.04 mg/kg that was administered when patients were observed to swallow. ETT was chosen using the formula age/4 + 4.5. All ETT were uncuffed. P-LMA was chosen according to reference written on the products manual. Following ETT or P-LMA placement, bilateral lung auscultation was performed and ventilation was confirmed using a capnograph. Epigastric auscultation was performed to determine air leakage. When air leakage was detected, P-LMA was reintroduced. Patients with air leakage following two placements were intubated and excluded from the study. For patients with air leakage after ETT, patients were re-intubated using a 0.5 larger size tube. Patients who had air
leakage after second intubation and patients with 2 or more failed intubation attempts were excluded from the study as peri and postoperative outcome measures may be effected.
1.2. Patient monitoring All patients underwent monitoring using electrocardiography, pulse oximetry, non-invasive blood pressure monitoring, capnography and EtCO2. Following induction, 8–14-Fr tube was placed orogastrically. Gastric content and air were aspirated and the orogastric tube was removed. P-LMA or ETT was placed immediately after this aspiration. Following intubation or P-LMA placement, a 8–14-Fr tube was attached to the pressure transducer using a three way stopcock. The nasogastric tube was filled with sterile saline and pressure transducer was zeroed. The nasogastric tube was lubricated and in groups 1 and 2 placed orogastrically and in groups 3 and 4 placed through the P-LMA's drainage port. Pressure measurements were made using the anterior axillary line at the level of the xiphoid process as a reference point. Pressure measurements were made using the hydrostatic pressure measurement technique reported previously [5].
1.3. Surgical technique Inguinal hernia repair was performed in the supine position, using the PIRS (percutaneous internal ring suturing) technique in all patients, as previously described [2]. Insufflation pressure was set at 8 cmH2O for all patients.
1.4. Intraoperative measurements Following skin preparation and sterile draping of patient, EtCO2, IGP, insufflation pressure, SpO2, HR, and Ppeak were measured at 0th minute (basal) and every minute while the surgical procedure lasted. Insufflation pressure was monitored from the laparoscopy device. All other measurements were recorded from the anesthesia device. Surgical time was defined as time from beginning of skin preparation to completion of umbilical and inguinal wound dressing. Anesthesia time was defined as time from induction to removal of airway device. Recovery time was defined as time from removal of airway device to modified Aldrete score of 9 or above. Events such as aspiration, vomiting, laryngospasm, movement or muscle contraction, response to surgical stimulus, swallowing etc. were noted. Patients were followed for any complications during awakening, recovery and for 2–6 h postoperatively. All patients received 10-mg/kg IV paracetamol preoperatively as well as local anesthetic injection to port site. Patients were taken to recovery room after adequate respiratory effort was observed. Patient was transferred to the ward when the modified Aldrete score was 9 or above, and time was noted. Recovery room and ward staff were blinded to the group of the patients.
1.5. Outcome measures During the design phase of the study, primary outcome measures were planned as intragastric pressure, P-peak and insufflation pressures and their relationship and secondary outcome measures were planned as time under anesthesia, surgical time and perioperative or postoperative anesthesia-related problems. Methods used when the detailed anesthesia regimes were used or when patients responded to surgical stimuli, the effect of additional drugs on anesthesia and surgical times were later added as secondary measures. Sample size was determined by authors using data from previous studies [5,13,14].
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Fig. 1. CONSORT flow diagram.
1.6. Statistical analysis All analysis was performed by two authors (IB and BC) who were both blinded. SPSS 16.0 Statistical package programme (SPSS, Chicago, IL, USA) was used for statistical analysis. Variables were evaluated for normal distribution using the Kolmogorov–Smirnov test. Mean ± standard deviation was used for descriptive statistics. Ratios were compared using chi square. Continuous variables were compared using one way ANOVA with post hoc Tukey analysis. A p-value of b 0.05 was considered statistically significant. 2. Results Each group consisted of 20 patients. In order to reach 80 patients, 94 patients were assessed for eligibility. Of these patients 12 did not meet inclusion criteria or met exclusion criteria and 2 patients' parents refused to participate in the study. No patient in groups 1 or 2 were difficult intubation or ventilation. One patient in group 2 was found to have bilateral patient processus vaginalis and was excluded from the study. One patient in group 4 had persistent air leakage despite reintroduction of P-LMA and therefore required intubation and was excluded from the study. Therefore groups 2 and 4 had 19 and groups 1 and 3 had 20 patients at final analysis. CONSORT flowchart is shown in Fig. 1.
Demographic information (age, sex and weight) are shown in Table 1. There was no statistical difference between groups with regard to demographic data. Anesthesia time, surgical time and recovery time averages for each group are shown in Table 2. Average surgical time was longest in group 4 (15.1 m) and shortest in group 1 (13.6 m). There was no statistical difference between the average surgical times between groups. The shortest and longest average anesthesia time was observed in group 4 and group 1, respectively (26.4 m vs. 37.1 m). There was a statistically significant difference between the average anesthesia times between groups (p b 0.001). There was a statistically significant difference between group 1 vs. group 2 (p = 0.023), group 1 vs. group 3 (p b 0.001) and group 1 vs. group 4 (p b 0.001). There was no statistically significant difference between group 2 vs. group 3 (p = 0.510), group 2 vs. group 4 (p = 0.09) and group 3 vs. group 4 (p = 0.754). The shortest and longest average recovery time was also observed in group 4 and group 1 respectively (7.5 m vs. 14.5 m) and recovery time were observed in group 4 and group 1, respectively. There was a statistically significant difference between groups 1–3, groups 1–4, groups 2–3 and groups 2–4 (p b 0.001, p b 0.001, p = 0.002 and p b 0.001 respectively). No statistically significant difference was found between group 1 vs. group 2 (p = 0.948) or group 3 vs. group 4 (p = 0.471). Intragastric pressure and peak airway pressure (Ppeak) for each group are shown in Table 3. Box plot of basal intragastric pressure,
Table 1 Demographic information, *: one way ANOVA, **: chi square.
Age (y) 1 Sex (M/F) Weight (kg)
Group 1 (n = 20)
Group 2 (n = 19)
Group 3 (n = 20)
Group 4 (n = 19)
p
5.1 ± 1.8 13/7 18.5 ± 5.6
4.9 ± 0.9 12/7 16.3 ± 4.6
5.3 ± 1.5 14/6 20.2 ± 6.3
5.5 ± 1.9 12/7 17.5 ± 6.6
0.675* 0.965** 0.205*
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Table 2 Comparison of anesthesia time, surgical time and recovery time between groups. * ANOVA with post hoc Tukey analysis.
Anesthesia time Surgical time Recovery time
Group 1 (n = 20)
Group 2 (n = 19)
Group 3 (n = 20)
Group 4 (n = 19)
p
37.1 ± 5.6 13.6 ± 2.7 14.5 ± 4.0
31.2 ± 7.2 13.8 ± 2.4 13.9 ± 3.4
28.4 ± 5.8 14.3 ± 1.9 9.1 ± 2.6
26.4 ± 6.1 15.1 ± 3.6 7.5 ± 3.6
b0.001 0.345 b0.001
Table 3 Comparison of intragastric pressure (IGP) and peak airway pressure (Ppeak), *: ANOVA. Group 1 (n = 20) Basal IGP Average IGP during insufflation Basal Ppeak Average Ppeak during insufflation
Group 2 (n = 19)
Group 3 (n = 20)
Group 4 (n = 19)
p
10.7 ± 2.2 11.3 ± 2.2 11.3 ± 2.8 11.6 ± 1.7 0.579* 13.8 ± 2.5 14.1 ± 2.8 15.9 ± 2.9 15.7 ± 3.3 0.053* 14.8 ± 2.3 14.2 ± 2.1 15.3 ± 2.0 15.9 ± 2.2 0.087* 15.4 ± 2.6 15.5 ± 2.3 16.6 ± 2.4 17.0 ± 2.9 0.132*
There was no response to umbilical incision in groups 1, 2 or 3. In group 4, 7 patients were observed to respond to incision. All 7 patients were administered a single dose of 1 mg/kg intravenous propofol and surgeries were completed thereafter. No perioperative complications were observed. During the postoperative period, one patient in group 1 had coughing and one patient in groups 2, 3 and 4 respectively complained of a sore throat. No additional anesthesia was required in any patient.
3. Discussion
average intragastric pressure during insufflation, average basal Ppeak and average Ppeak during insufflation is shown in Fig. 2. There was no statistically significant difference between groups with regard to basal intragastric pressure, average intragastric pressure during insufflation, basal Ppeak and average Ppeak during insufflation. Basal intragastric pressure was higher in group 4 when compared to other groups, but the difference was not statistically significant. No patients' intragastric pressure was observed to pass 20 cmH2O. Ppeak was found to increase in correlation with IGP. No significant change in SpO2 or EtCO2 was observed during insufflation for any groups. All patients' insufflation pressure was set and remained at 8 cmH2O during the procedure, giving adequate surgical field view.
Our data have shown that, similar to ETT intubation, P-LMA is safe in children undergoing short-lasting surgical procedures such as inguinal hernia or communicating hydrocele repair using PIRS technique. In children undergoing short-lasting surgical procedures with low insufflation pressures, safe anesthesia management can be obtained using P-LMA with no muscle relaxant or with subparalytic doses. Endotracheal intubation is considered to be safer when compared to LMA in general anesthesia practices. However, LMA is reported to be safely used in all age groups for various surgical procedures [15,16]. Anesthesiologist avoided the use of LMA for laparoscopic procedures because of the fear of airway safety issues secondary to abdominal insufflation [8]. The use of muscle relaxants in laparoscopic surgery offer increased visibility of the surgical field and decrease the risk of
Fig. 2. Box plot for basal intragastric pressure (A), average intragastric pressure during insufflation (B), basal peak airway pressure (C), and average peak airway perssure during insufflation (D) of groups showing minimum, first quartile, median, third quartile and maximum pressures.
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complications because of patient movement while trocars or laparoscopic hand tools are in place. However, the use of muscle relaxants are associated with increased mortality and anesthesia-related complications [17]. Recently studies have been reporting the safety of LMA use in both adults and children [7,8,18]. In adult patients, the use of LMA has been reported in patients undergoing laparoscopic cholecystectomy and laparoscopic gynecological procedures. It is important to note that one study of laparoscopic gynecological procedures reported the use of subparalytic doses of muscle relaxants with LMA [19], as has several studies of LMA use in laparoscopic cholecystectomy procedures [9,20,21]. Chen et al. [22] investigated the requirement of muscle relaxants for laparoscopic gynecological procedures performed with P-LMA. All patients underwent surgery using P-LMA and the authors reported no difference in patient satisfaction, surgical time and recovery time between patients who underwent the procedure with or without muscle relaxant. In patients undergoing a surgical procedure using LMA, the effect of abdominal insufflation on gastric distention and ventilation has been a topic of interest and several studies using different types of LMA have been performed [5,9,23]. Gastric distention negatively effects the field of view in upper gastrointestinal surgery such as laparoscopic cholecystectomy. Gastric distention is a subjective criteria and therefore the measurement of intragastric pressure is more valuable. One study reported that intraabdominal pressure as measured using an intravesical catheter, significantly correlated with intragastric pressure measurements [24]. While the evidence on the relationship between intragastic pressure and intraabdominal pressure in children is conflicting, intragastric pressure is commonly used as it is a simple and noninvasive technique to reflect intraabdominal pressure [25]. High intraabdominal and therefore intragastric pressures may lead to the regurgitation and aspiration of gastric contents in patients with LMA, with potential fatal consequences. Our study demonstrated that under low insufflation pressures, intragastric pressure was only minimally affected. Ozdamar et al. [5] compared ventilation parameters and intragastric pressures in children undergoing laparoscopic procedures with ETT and LMA, and reported that LMA is a safe alternative to ETT. In their study, vecuronium (0.08 mg/kg) - a steroid-structured non-depolarising muscle relaxant was used for ETT and LMA. Average insufflation times were over 50 min. However, many pediatric laparoscopic procedures last shorter nowadays. The PIRS procedure we used in this study lasts between 15 and 20 min and therefore the use of long-acting muscle relaxant was not necessary in either the ETT or LMA groups. Miranov et al. [6] concluded that classical LMA can be used in shortlasting pediatric laparoscopic surgery in patients without respiratory disease. They reported that LMA decreased awakening time. However, the average surgical time was 50 min. In this study, patients underwent a relatively short laparoscopic procedure where low insufflation pressures are adequate for good view of surgical field. Intubation with remifentanil may also be an alternative as was performed in group 2. However, both subparalytic doses of rocuronium with P-LMA and P-LMA without muscle relaxant are both safe alternative methods. Both these methods lead to shorter time under anesthesia and faster recovery times. Our study has several limitations. Because of a pediatric population of differing ages, we were unable to evaluate some postoperative complications such as sore throat. We measured intragastric pressures but did not have any method of confirming the location of the tube. A tube misplaced in the esophagus or duodenum would have given misleading results. Ultrasonography to confirm the location of the nasogastric tube would have been useful. The choice of drug and dosage difference at induction was different for all groups. This can be considered as a limitation. However, our aim was not to compare the effect of different drugs on anesthesia or surgical time, but to compare four different combination of drugs and airway devices. We could have used pH monitoring, especially in patients where LMA was used, in order to evaluate any micro-aspirations.
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It must be noted that, our study population is of a very specific group of patients, with an average age of 5.2 years using an insufflation pressure of 8 mmH2O in surgeries lasting around 15 min. We observed four patients with anesthesia-related complications. Although we determined our sample size according to previous studies, anesthesiarelated complications are rare and would require a larger sample size to accurately determine. Our data may not be generalisable to the whole pediatric population. However, we believe that this study will form a basis for further research. In conclusion, the use of muscle relaxants in short-lasting laparoscopic procedures in children is not absolutely necessary and LMA with subparalytic dose of muscle relaxant or with no muscle relaxant is a safe alternative, although this may not be generalisable for all pediatric age groups or procedures. Conflict of interest The authors have no conflict of interest to declare. Funding The authors received no funding for this study. References [1] Chang S-J, Chen JY-C, Hsu C-K, et al. The incidence of inguinal hernia and associated risk factors of incarceration in pediatric inguinal hernia: a nation-wide longitudinal population-based study. Hernia 2015. http://dx.doi.org/10.1007/s10029-015-1450-x. [2] Thomas DT, Göcmen KB, Tulgar S, et al. Percutaneous internal ring suturing is a safe and effective method for the minimal invasive treatment of pediatric inguinal hernia: experience with 250 cases. J Pediatr Surg 2016;51(8):1330–5. [3] Li S, Li M, Wong KKY, et al. Laparoscopically assisted simple suturing obliteration (LASSO) of the internal ring using an epidural needle: a handy single-port laparoscopic herniorrhaphy in children. J Pediatr Surg 2014;49:1818–20. [4] McClain L, Streck C, Lesher A, et al. Laparoscopic needle-assisted inguinal hernia repair in 495 children. Surg Endosc 2015;29:781–6. [5] Ozdamar D, Güvenç BH, Toker K, et al. Comparison of the effect of LMA and ETT on ventilation and intragastric pressure in pediatric laparoscopic procedures. Minerva Anestesiol 2010;76:592–9. [6] Mironov PI, Estekhin AM, Mirasov AA. Anaesthetic maintenance with laryngeal mask for a laparoscopic surgery in pediatric patients. Anesteziol Reanimatol 2013: 10–4. [7] Sinha A, Sharma B, Sood J. ProSeal as an alternative to endotracheal intubation in pediatric laparoscopy. Paediatr Anaesth 2007;17:327–32. [8] Patel A, Clark SR, Schiffmiller M, et al. A survey of practice patterns in the use of laryngeal mask by pediatric anesthesiologists. Paediatr Anaesth 2015;25:1127–31. [9] Cha SM, Park S, Kang H, et al. Gastric distension with SLIPA versus LMA ProSeal during laparoscopic cholecystectomy: a randomized trial. Surg Laparosc Endosc Percutan Tech 2014;24:216–20. [10] Brain AIJ, Verghese C, Strube PJ. The LMA “ProSeal”—a laryngeal mask with an oesophageal vent. Br J Anaesth 2000;84:650–4. [11] Sharma V, Verghese C, McKenna PJ. Prospective audit on the use of the LMASupreme TM for airway management of adult patients undergoing elective orthopaedic surgery in prone position. Br J Anaesth 2010;105:228–32. [12] Aydogmus MT, Turk HSY, Oba S, et al. Can SupremeTM laryngeal mask airway be an alternative to endotracheal intubation in laparoscopic surgery? Braz J Anesthesiol 2014;64:66–70. [13] Engum SA, Kogon B, Jensen E, et al. Gastric tonometry and direct intraabdominal pressure monitoring in abdominal compartment syndrome. J Pediatr Surg 2002; 37:214–8. [14] Moragas G, Azpiroz F, Pavia J, et al. Relations among intragastric pressure, postcibal perception, and gastric emptying. Am J Physiol 1993;264:G1112–7. [15] Sanket B, Ramavakoda CY, Nishtala MR, et al. Comparison of second-generation supraglottic airway devices (i-gel versus LMA ProSeal) during elective surgery in children. AANA J 2015;83:275–80. [16] Yao T, Yang X-L, Zhang F, et al. The feasibility of supreme laryngeal mask airway in gynecological laparoscopy surgery. Zhonghua Yi Xue Za Zhi 2010;90:2048–51. [17] Ledowski T. Muscle relaxation in laparoscopic surgery: what is the evidence for improved operating conditions and patient outcome? A brief review of the literature. Surg Laparosc Endosc Percutan Tech 2015;25:281–5. [18] Timmermann A, Bergner UA, Russo SG. Laryngeal mask airway indications: new frontiers for second-generation supraglottic airways. Curr Opin Anaesthesiol 2015; 28:717–26. [19] Griffiths JD, Nguyen M, Lau H, et al. A prospective randomised comparison of the LMA ProSeal (TM) versus endotracheal tube on the severity of postoperative pain following gynaecological laparoscopy. Anaesth Intensive Care 2013;41:46.
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