Tu1379 ECG Monitoring During Moderate Sedation: Less Is More

Abstracts

it can be also cost saving. (*) ASA: Clinical patients’ Classification according to American Society of Anesthesiologists.

Tu1378 Sedation for Colonoscopy: a Clinical Trial Comparing the Use of Propofol and Fentanyl With or Without Midazolam Jose Francisco N. Pereira DAS Neves1, Mariana Moraes P. Neves Araujo1, Clarice M. Ferreira1, Fabiana B. Neves Duarte1, Fabio H. Pace1, Laura C. Halfeld1, Fernando P. Araujo1, Todd H. Baron2, Lincoln E. Ferreira*1 1 GIE, UFJF, Juiz de Fora, Brazil; 2GI, Mayo Clinic, Rochester, MN Background: Colonoscopy is one of the most common procedures in the world. Pain during colonoscopy may difficult the procedure and reduce patient satisfaction. Thus, many patients prefer that the examination be performed under sedation and analgesia. However, the optimal sedation for colonoscopy is yet to be defined. Objectives: To evaluate the side effects of sedation, conditions for discharge from the post-anesthesia recovery room, quality of sedation in the opinion of the endoscopist and the patient, and the propofol consumption. Material and Methods: This was a prospective, double-blind study, in which 140 patients were randomized into 2 groups of 70 patients who received propofol, fentanyl, and midazolam (group I) or propofol and fentanyl (group II). The study endpoints were to evaluate sedation-related adverse events, conditions at the time of discharge from the recovery room, and quality of sedation as judged by the endoscopist and the patient. A secondary endpoint was to evaluate total propofol dosage. Results: The intergroup distribution by sex and age was similar. Regarding the examination, higher incidence of reaction (motor or verbal) to the introduction of the colonoscope was observed in group II patients (P ⬍ 0.04) than in group I patients. Further, group II showed a higher incidence of hypotension (P ⫽ 0.121) and more number of episodes of bradycardia (P ⫽ 0.04) than that in group I. Only 1 episode of mild hypoxemia was noted in both the groups. The mean propofol dose used for inducing anesthesia was similar in both groups; however, the total propofol consumption was higher in group II (153⫾60.3 vs. 206⫾79.2, P ⬍ 0.001). Patient satisfaction was significantly higher in group I (P ⫽ 0.006) than in group II. Conclusion: The combination of midazolam with propofol and fentanyl for sedation in colonoscopy reduces the total propofol consumption and ensures greater patient satisfaction.

Tu1379 ECG Monitoring During Moderate Sedation: Less Is More Brandon M. Craft*, Tica Bollinger, Phyllis Malpas, Paul Nietert, Ryan Tober, Melissa Youngblood, Brenda J. Hoffman Department of Gastroenterology, Medical University of South Carolina, Charleston, SC

Tu1377 Endoscopists Directed Propofol Administration (EDPA) in a Community Hospital in Ksa Iyad M. Subei*, Omar AL-Subee Medicine, Jeddah Center for Liver and Digestive Diseases; Erfan & Bagedo General Hospital, Jeddah, Saudi Arabia Background: Conventional Benzodiazepines and opioids-based sedations have not proven to provide optimal sedation due to their sedative effect that lasts for a long time after the procedures are completed.Propofol is an ultra short acting substance that is generally used by Anesthesiologist. However it provides a sedative and amnestic effect at its subhypnotic doses . This unique feature encouraged using it in incremental small doses as a safe and effective sedative. Nevertheless, until recently, its use has been restricted to anesthesia service in many countries; although several large studies worldwide have proved that EDPA is a very safe and effective modality to be used in GI endoscopy. Methods: In a retrospective analysis, a total of 18,407 procedures done with EDPA based-sedation including all diagnostic and therapeutic endoscopic G.I. procedures (EGD, ERCP, EUS and colonoscopy between Feb.2000 and Oct.2012. In all patients (Pt’s.), IV Propofol was infused by a trained nurse but directed by the endoscopist performing the procedures. All Pt’s were ASA* Class I and II; their ages ranged between 15 and 70 years. On the other hand, critically ill Pt’s. (ASA ⬎ III, those predicted to have difficult endotracheal intubation, & those in need to protect their airway due to massive upper G.I. bleeding were excluded . All endoscopy staff have attended special training course in providing sedation, & BLS certified; at least one ACLS certified staff is present in each endoscopy session. Continuous 02 flow of a 2-5 liters/sec through nasal cannula was prophylactically provided to all Pt’s., and all were monitored with pulse oximetry & BP measuring during the procedure and the recovery until the patients leave the unit. Results: Out of 18407 procedures, no mortality was reported. Only one pt. developed TIA recovered completely in less than 2 hours and one patient developed MI needed percutaneous coronary intervention. One Pt. who developed massive UGI bleeding during the procedure required endotracheal intubation. In 17 Pt’s. , the procedure was aborted because Pt’s. 02 saturation dropped to ⬍ 85%, but all regained their full consciousness and their normal 02 saturation in few minutes after resuscitation with mask ventilation. The rest of 18,386 patients, no deleterious event was observed during the procedure and the recovery. Conclusion: Our data confirms previous studies that EDPA based sedation if properly used on ASA I & II patients, is not only safe & effective, but

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Purpose: Despite the lack of national society recommendation or data to support its usage, ECG monitoring during moderate sedation has become commonplace. ECG monitoring in an endoscopy unit requires additional training for the endoscopy nurses and purchase of monitoring equipment. Interruptions in procedures due to lead malfunction may occur and decrease room efficiency. In addition, changes in ECG may lead to intensive and costly evaluation without ultimate gain. The purpose of this study was to determine the rate of clinically significant dysrhythmias in healthy persons undergoing moderate sedation utilizing continuous electrocardiography. Methods: Consecutive ASA I or II patients presenting for outpatient endoscopy undergoing moderate sedation were included. All patients had a pre-procedure 6 second telemetry ECG taken. The patients then had continuous ECG monitoring during the entirety of the procedure. Any pre or intra-procedural abnormalities were noted and evaluated by the M.D. The nurses prospectively recorded and noted whether changes resulted in time delays, required cardiac consultation or medications. Chart review was conducted of the patients experiencing an ECG change including consultation and outcome. Results: 3472 patients met inclusion criteria. The mean age was 56.8 (range 18-90) years. 58% were female, 64% Caucasian, 74% presented for colonoscopy. Subjects that showed any change in pre to intra-op ECG were significantly older than subjects that did not show a change (p ⫽ 0.029, 56.8 years vs. 63.3 years). 20 patients were noted to have any change during the procedure. Only five patients, average age 71.1, were noted to have rhythm change during the procedure felt to be significant after cardiology review. Sinus tachycardia, premature ventricular contractions, bigeminy, and sinus bradycardia without hemodynamic compromise were considered insignificant events. One patient with an existing LBBB became tachycardic and the procedure was terminated. That person refused cardiac evaluation and refused to return for further procedures. 2 patients, both with non-sustained vtach, underwent outpatient cardiology evaluation with no clinical significant diagnosis made. An additional two patients also with brief non-sustained v-tach had no further testing. The overall rate of detecting clinically significant dysrhythmias was 0.14% (95% CI 0.01%-0.30%). Conclusion: The use of continuous EKG monitoring in ASA I or ASA II patients undergoing outpatient endoscopy with moderate sedation does not yield clinically relevant information

Volume 77, No. 5S : 2013

GASTROINTESTINAL ENDOSCOPY

AB519

Abstracts

in younger individuals without known cardiac disease. Monitoring may lead to additional expense including cardiac evaluation with low clinical yield. Additional studies are needed to further delineate if patients older than 60 may benefit from continuous ECG monitoring during outpatient endoscopy.

Tu1380 Multicenter Preliminary Experience With the SEDASYS Propofol Infusion Pump for Colonoscopy in Routine Clinical Practice: Safety and Endoscopist Satisfaction Anand Sahai*1, John C. Wong2, Michael Gould3, Michael F. Byrne2 1 CHUM-Hopital Saint Luc, Montreal, QC, Canada; 2Vancouver General Hospital/University of British Columbia, Vancouver, BC, Canada; 3Vaughan Endoscopy Clinic, Vaughan, ON, Canada Background: When the endoscopy team includes only 1 nurse and 1 physician, the Sedasys propofol infusion pump, which is operated by the nurse, uses patient BMI to calculate the estimated infusion rate required to maintain light to moderate sedation for colonoscopy in ASA 1-2 patients that have been premedicated with a single 100␮g dose of fentanyl. It then continuously monitors O2 saturation, capnography, respiratory rate, and patient responsiveness and lowers or stops the infusion as needed. If the physician wishes to increase the rate or give a PRN dose, the system will only allow so if the system’s algorithm deems the patient’s sedation level is not too deep. Aim: To report our early experience with Sedasys in routine clinical practice. Methods: Consecutive available case records and any available Sedasys case summary printouts from 3 centres (2 hospitals, 1 ASC) currently using Sedasys were reviewed for all available pertinent information. Results: As per product instructions, Sedasys was used only for colonoscopy patients, ⬍70 yrs old, ASA 1-2, BMI ⬍30, and with no history of sleep apnea. Since 2011, Sedasys was used in over 500 patients in 3 Canadian centers. Data for study purposes were available for 311 patients: 50% female, mean age 54⫾11, mean BMI 26⫾4. Primary indications were: screening 50%, bleeding 21%, other symptoms 17%, IBD 12%. All colonosocopies were completed to the cecum. Mean procedure length was 18⫾7 min. Mean propofol dose: 87⫾41mg [median 79mg]. O2 SAT%: mean ⌬ -3.1⫾3.9, mean minimum: 95⫾4.1. Desaturation episodes: ⬍92%: 17%, ⬍85%: 2%. BPmmHg: mean ⌬: -24⫾18, mean minimum: 107⫾16. Hypotension: ⬍90mmHg: 14%, ⬍80mmHg: 3%. Endoscopist satisfaction: Of 14 users surveyed anonymously: 86% liked Sedasys, 86% found it more effective than endoscopistadministered non-propofol sedation, 100% found it convenient to use, and 93% would recommend it at least slightly strongly. Conclusions: Early clinical experience suggests that Sedasys is as safe as regular sedation, but is preferred by endoscopists to conventional, endoscopist-administered non-propofol sedation.

Tu1381 ERCP Is Safe in Patients Aged 90 and Above Ratna Pandey*, Mohid S. Khan, Kalpesh Besherdas, Niall M. Van Someren Gastroenterology, Chase Farm Hospital, Middlesex, United Kingdom Background: The ageing population in the UK means that biliary diseases are becoming more common. Endoscopic Retrograde Cholangiopancreatography (ERCP) is therefore increasingly being used as a therapeutic strategy. However, the elderly population often have associated co-morbidities and poorer physical health, which would suggest that ERCP may be technically more challenging, or of higher risk in this group. We look at the safety of ERCP in patients over 90. Methods: Patients aged 90 or above who underwent ERCP from October 1999 to October 2012 were studied retrospectively. The data was extracted from a single centre computer ERCP database. Results: ERCPs performed in patients aged 90 or above represented 6.5% of a total of 4017 procedures. The age range of patients was from 90 to 103 years. Therapeutic intervention was required in 246/262 procedures (93.9%). 16 specific types of intervention were performed, with the majority being sphincterotomy (62.2%) or stent insertion (16.7%). The procedure related mortality was 0.76% (2/262). 1 death occurred following a significant bleed post sphincterotomy, the other death resulted from a retroperitoneal perforation following duodenal dilatation. Complications occurred in 5.3% (14/ 262) of procedures. The most frequently occurring complications were bleeding and cholangitis, each of which occurred in 3/262 (1.1%) patients. Perforation occurred in 2/262 patients (0.76%). Pancreatitis did not occur in any of the patients. There were no complications related to co-morbidity. Conclusion: The number of ERCPs being performed in elderly patients is likely to increase. The procedure related mortality and morbidity is comparable with national figures. ERCP in this group is safe, practical and has a definite therapeutic benefit in a large proportion of patients.

Tu1382 Safety and Efficacy of Moderate Sedation for Tandem EUS and ERCP Fatema S. Uddin*, Pragathi Kandunoori, Deepak Agrawal, Jayaprakash Sreenarasimhaiah Division of Digestive and Liver Diseases, UT Southwestern, Dallas, TX Background: Endoscopic ultrasound (EUS) is being used more frequently as a diagnostic tool prior to therapeutic endoscopic retrograde cholangiopancreatography (ERCP) for suspected choledocholithiasis. Many gastroenterologists now prefer deep sedation or general anesthesia for EUS ⫹/⫺ ERCP procedures due to concerns of a longer duration and the adequacy of moderate sedation. Using anesthesiology services can substantially add to the total cost of the procedure. EUS in this setting is a relatively short procedure and does not necessarily require anesthesia. Furthermore, anesthesiology services are not widely available in all locations which may lead to unnecessary procedure delays. Aim: To assess the safety and efficacy of moderate sedation during tandem EUS and ERCP. Methods: We retrospectively identified all patients who underwent tandem EUS and ERCP at a large academic institution from 2008 2012. Inclusion criteria were performance of EUS and ERCP at the same session and indication of suspected bile duct stones. Information was collected on demographics, type of sedation, mean dosages and outcome of procedures. High doses of medications were defined to be ⱖ10mg of midazolam or ⱖ200mcg of fentanyl (or the equivalent meperidine dose of 150mg). Results: 1615 charts were reviewed. 226 patients were identified as having tandem EUS and ERCP for choledocholithiasis. 172 (76%)of these patients were females and the average age was 44.8 years. 38 patients (16.8%) received anesthesia provided by an anesthesiologist and 188 (83.2%) received moderate sedation provided at endoscopist’s discretion. There were no adverse events documented for these procedures performed during this time period. Technical success rate at relieving choledocholithiasis was 97% (219). 4 patients (2%) failed moderate sedation and ultimately required anesthesia. Conclusions: This study demonstrates that most patients can safely undergo tandem EUS and ERCP with moderate sedation in the evaluation and treatment of choledocholithiasis. We offer that moderate sedation is as safe and effective as deep sedation or general anesthesia and does not adversely affect patient outcomes. In a subset of patients who received high doses of medications, there were no adverse outcomes. EUS ⴙ ERCP for Choledocholithiasis

Number of patients Average dose given

Midazolam (mg)

Fentanyl (mcg)

Demerol (mg)

Benadryl (mg)

186 9.1

135 197

49 151

168 50

EUS ⴙ ERCP for Choledocholithiasis Where High Doses of Medications Were Required

Number of patients Average dose given

Midazolam (mg)

Fentanyl (mcg)

Meperidine (mg)

68 13.7

65 261

27 187

Tu1383 Assessment of Feasibility of Non-Anesthesiologist-Assisted ERCP Based on Performance Status in Patients Over 70 Hyoung-Chul OH*1, Jae Hyuk Do1, Jung Sik Choi2 1 Gastroenterology, Chung-Ang University College of Medicine, Seoul, Republic of Korea; 2Gastroenterology, Inje University College of Medicine, Busan Paik Hospital, Busan, Republic of Korea Background: Endoscopic retrograde cholangiopancreatography (ERCP) has been increasingly performed in the elderly patients. There were few reports that suggested the objective criteria to assess the feasibility for safe ERCP. This study evaluated the usefulness of an algorithm that assessed the patient’s feasibility based on performance status and cardiopulmonary parameters. Methods: Patients older than 70 years who were indicated for ERCP were prospectively enrolled and risk-stratified by assessing their performance status by ECOG performance status, ASA physical status, Duke activity status index (DASI), and cardiopulmonary parameters (pulse oxymeter, ABGA, FEV1 if necessary). ERCPrelated parameters and complications were monitored and compared between the 70s (group A, n⫽195) and 80s (group B, n⫽86). Overall serious event was defined as no initial ERCP trial, early ERCP termination and major ERCP-related complications. Results: There was no significant difference in underlying diseases and ERCP indications. ERCP was not performed in six high-risk patients for procedure. For performance status, there were significant differences in mean DASI (23.1 vs. 14.9, p⬍0.01) and ECOG performance status(3-4, 49/195 vs. 33/ 86, p⬍0.05) between group A and B. Major ERCP-related complications (hypotension, severe bradycardia, hypoxia, myocardial infarction, cerebral

AB520 GASTROINTESTINAL ENDOSCOPY Volume 77, No. 5S : 2013

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