- Email: [email protected]
A Randomized Prospective Trial Comparing Different Regimens of Oral Sodium Phosphate and Polyethylene Glycol Solution for Colonoscopy Preparation
*S1560 A Randomized Prospective Trial Comparing Different Regimens of Oral Sodium Phosphate and Polyethylene Glycol Solution for Colonoscopy Preparation Emilie Jolicoeur, Alaa Rostom, Sylvie Gregoire, Dilip Patel, Catherine Dube, Nav Saloojee, Cathy Lowe Background: Recent FDA and Health Canada statements warned physicians regarding the risk of electrolyte abnormalities if more than 45 ml of oral sodium phosphate solution was used in a 24-hour period in patients with or without risk factors. The purpose of this study was to compare the tolerability, safety and cleansing ability of different regimens of oral sodium phosphate fleet as well as a polyethylene glycol-based preparation (PEG) in healthy patients. Methods: One hundred patients undergoing routine colonoscopy were randomized to one of four purgative methods: 2 bottles of oral sodium phosphate solution; 6 hours apart (Group 1), 12 hours apart (Group 2), 24 hours apart (Group 3), and 4 L of PEG solution (Group 4). Bowel preparation, patient satisfaction and electrolyte imbalances were the measured endpoints. Continuous measures were analyzed using ANOVA and categorical measures were assessed using chi-square tests. Corrections for multiple comparisons were undertaken. Results: Overall bowel preparation quality did not differ between groups although a trend favoring Group 2 was observed. The PEG group had significantly more colonic fluid than the other groups (p=0.01). The quality was consistently worse in the right colon for all groups (p=0.74). There was no difference in overall satisfaction with the regimens although Group 3 missed significantly more days of work (p=0.015). Tolerability was not different among groups and no clinically significant adverse events were identified. The three oral sodium phosphate groups were independently associated with a greater rise in serum phosphate than seen with the PEG group (p< 0.001). There were no differences in the increase in phosphate among the three sodium phosphate groups. There was no difference in the decrease in calcium among all groups. The three sodium phosphate groups were associated with a greater decrease in potassium than the PEG group (p=0.002) but no significant difference was noted among sodium phosphate groups. Conclusion: The PEG group had more colonic fluid at colonoscopy but was associated with less electrolyte changes than each of the oral sodium phosphate groups. In comparing the 3 sodium phosphate groups, the overall cleansing ability was similar with a trend favoring Group 2, there were no significant differences in electrolyte changes and Group 3 required more time off work. This study is ongoing.
*S1562 Non-anesthetist Administered Propofol for ERCP; Efficacy, Safety Profile and Side Effect: A Prospective Randomized Trial Pradermchai Kongkam, Bubpha Pornphisarn, Rungsun Rerknimitr Introduction: Traditionally ERCP is performed under conscious sedation. Sedative agents are mainly intravenous midazolam and meperidine. These agents have many disadvantages because of difficulty on titrating the dose and delayed recovery effect. Propofol has become a popular agent for upper and lower gastrointestinal endoscopy due to its rapid recovery profile. This study is undertaken to evaluate the safety and recovery period of patients who undergo ERCP with propofol compared to conventional sedative agents. Methods : From July 2003 - November 2003, patients who required ERCP (n=75) were prospectively randomized to be sedated with intravenous midazolam/meperidine (n=34) and continuous intravenous propofol(n=41). These agents were administered by gastroenterology fellows. Vital sign and oxygen saturation were monitored with automated equipment. Oxygen supplement was provided intermittently only when the oxygen saturation dropped below 90%. Results: Baseline demographic datas were similar : age, sex, BMI, time before insertion of endoscope, procedural time, baseline blood pressure, oxygen saturation and HR. Six and thirteen patients in propofol and pethidine/midazolam group had at least one episode of oxygen saturation less than 90% (p = 0.019), respectively. But other physiological outcomes were not statistically different. At 30 minutes post sedation, more than 95% of propofol group had complete recovery compared to only 55.5% in meperidine/midazolam group. Conclusion : Continuous IV drip propofol is safe for patient undergoing ERCP. The incidence of hypoxemia is less, the recovery time is shorter significantly compared to conventional sedation. It could be used under gastroenterologist’s supervision without significant adverse event compared with conservative meperidine/midazolam sedation for ERCP.
*S1561 Moderate-Level Sedation During Endoscopy Using Low-Dose Propofol, Midazolam and an Opioid Lawrence B. Cohen, Charles D. Hightower, Daniel A. Wood, Kenneth M. Miller, James Aisenberg Background: Propofol provides several benefits for endoscopic sedation compared to benzodiazepines and opioids, including faster recovery and improved patient satisfaction. However, concern about the risk of deep sedation with propofol has limited its use by gastroenterologists. This study was designed to evaluate the level of sedation during endoscopy performed using low-dose propofol, midazolam, and an opioid. Methods: We prospectively studied 100 patients undergoing outpatient endoscopy. Sedation was performed according to our established protocol (Gastrointest Endosc 2003;58:725). An independent observer assessed the level of sedation using the ASA scale at 2-minute intervals throughout each procedure. Recovery was evaluated using 3 neuropsychometric tests. Recovery was complete when at least 2 out of 3 test scores returned to baseline values. All patients completed a postprocedure satisfaction survey as well as a 24-hour follow-up questionnaire. Results: Details of the medication dosing and procedural times are shown below. There were 729 assessments of sedation, 628 during colonoscopy and 101 during EGD. The level of sedation was minimal, moderate and deep in 77%, 21%, and 2%, respectively. There were 13 episodes of deep sedation, 9 during colonoscopy (1%) and 4 during EGD (4%). Physiologic measures remained stable throughout these 13 events and no intervention was required. During colonoscopy, deep sedation was more likely in patients with lower BMI and longer procedure time (p<0.01 for both). An analysis of the 13 deep sedation events will be presented. Ninety-eight percent of patients were satisfied with their endoscopic sedation, and 71% of patients returned to their usual activities within 2 hours of discharge. Conclusions: Endoscopic sedation with lowdose propofol combined with an opioid and midazolam retains the beneficial effects of higher dose propofol, but in contrast, most patients are only moderately sedated.
VOLUME 59, NO. 5, 2004
*S1563 A Prospective Randomised Single Blind Comparison of Three Methods of Bowel Preparation for Out-patient Flexible Sigmoidoscopy Anand L. Gidwani, Ragai R. Makar, Daphne Garrett, Robert Gilliland Introduction: Flexible Sigmoidoscopy is becoming the minimum standard for the investigation of colorectal symptoms. Preparation for out-patient sigmoidoscopy using one self-administered phosphate enema is the standard practice in our unit but provides acceptable bowel preparation in only 80% of patients. This study compared two methods of bowel preparation with the current standard in an attempt to improve efficacy and acceptability. Methods: From JanuarySeptember 2003, patients attending for out-patient flexible sigmoidoscopy were randomised to three groups: - Group 1: One Fleet enema two hours pre-procedure; Group 2: Two Fleet enemas, one on the evening prior to sigmoidoscopy and one two hours pre-procedure; Group 3: Lactulose 30mls orally 48 and 24 hours prior to sigmoidoscopy plus a single Fleet enema two hours pre-procedure. A patient questionnaire was used to assess side effects and tolerance. Endoscopists, who were blinded to the preparation used, completed questionnaires regarding procedure indication, preparation quality (excellent, good, fair, poor), depth of insertion, and findings. Power calculations were based on the 80% acceptable preparation rate obtained by using a single enema. An 80% probability of detecting a 10% difference in the quality of bowel preparation required a minimum of 70 patients per group. Results: 261 patients (Group 1: n=105; Group 2:n=81; Group 3:n=75) were included; endoscopist data was obtained in 96%. No difference was noted between the groups with regards age, gender, procedure indication, or grade of endoscopist. There was no difference between the groups in any of the patient acceptability variables examined (see table). There was no difference in the quality of preparation of patients in Group 1 vs. Group 2 (p=0.392) or Group 1 vs. Group 3 (p=0.132). However, lactulose + Fleet resulted in significantly fewer patients with acceptable preparation compared with two Fleet enemas (p=0.022). There was no difference between the groups in terms of depth of insertion or abnormalities noted. Conclusions: The addition of a Fleet enema or oral lactulose over and above a single fleet enema gives no significant improvement in the acceptability or efficacy of bowel preparation. 1 Chi-squared; 2 Fishers exact
GASTROINTESTINAL ENDOSCOPY
P127
*S1562 Non-anesthetist Administered Propofol for ERCP; Efficacy, Safety Profile and Side Effect: A Prospective Randomized Trial Pradermchai Kongkam, Bubpha Pornphisarn, Rungsun Rerknimitr Introduction: Traditionally ERCP is performed under conscious sedation. Sedative agents are mainly intravenous midazolam and meperidine. These agents have many disadvantages because of difficulty on titrating the dose and delayed recovery effect. Propofol has become a popular agent for upper and lower gastrointestinal endoscopy due to its rapid recovery profile. This study is undertaken to evaluate the safety and recovery period of patients who undergo ERCP with propofol compared to conventional sedative agents. Methods : From July 2003 - November 2003, patients who required ERCP (n=75) were prospectively randomized to be sedated with intravenous midazolam/meperidine (n=34) and continuous intravenous propofol(n=41). These agents were administered by gastroenterology fellows. Vital sign and oxygen saturation were monitored with automated equipment. Oxygen supplement was provided intermittently only when the oxygen saturation dropped below 90%. Results: Baseline demographic datas were similar : age, sex, BMI, time before insertion of endoscope, procedural time, baseline blood pressure, oxygen saturation and HR. Six and thirteen patients in propofol and pethidine/midazolam group had at least one episode of oxygen saturation less than 90% (p = 0.019), respectively. But other physiological outcomes were not statistically different. At 30 minutes post sedation, more than 95% of propofol group had complete recovery compared to only 55.5% in meperidine/midazolam group. Conclusion : Continuous IV drip propofol is safe for patient undergoing ERCP. The incidence of hypoxemia is less, the recovery time is shorter significantly compared to conventional sedation. It could be used under gastroenterologist’s supervision without significant adverse event compared with conservative meperidine/midazolam sedation for ERCP.
*S1561 Moderate-Level Sedation During Endoscopy Using Low-Dose Propofol, Midazolam and an Opioid Lawrence B. Cohen, Charles D. Hightower, Daniel A. Wood, Kenneth M. Miller, James Aisenberg Background: Propofol provides several benefits for endoscopic sedation compared to benzodiazepines and opioids, including faster recovery and improved patient satisfaction. However, concern about the risk of deep sedation with propofol has limited its use by gastroenterologists. This study was designed to evaluate the level of sedation during endoscopy performed using low-dose propofol, midazolam, and an opioid. Methods: We prospectively studied 100 patients undergoing outpatient endoscopy. Sedation was performed according to our established protocol (Gastrointest Endosc 2003;58:725). An independent observer assessed the level of sedation using the ASA scale at 2-minute intervals throughout each procedure. Recovery was evaluated using 3 neuropsychometric tests. Recovery was complete when at least 2 out of 3 test scores returned to baseline values. All patients completed a postprocedure satisfaction survey as well as a 24-hour follow-up questionnaire. Results: Details of the medication dosing and procedural times are shown below. There were 729 assessments of sedation, 628 during colonoscopy and 101 during EGD. The level of sedation was minimal, moderate and deep in 77%, 21%, and 2%, respectively. There were 13 episodes of deep sedation, 9 during colonoscopy (1%) and 4 during EGD (4%). Physiologic measures remained stable throughout these 13 events and no intervention was required. During colonoscopy, deep sedation was more likely in patients with lower BMI and longer procedure time (p<0.01 for both). An analysis of the 13 deep sedation events will be presented. Ninety-eight percent of patients were satisfied with their endoscopic sedation, and 71% of patients returned to their usual activities within 2 hours of discharge. Conclusions: Endoscopic sedation with lowdose propofol combined with an opioid and midazolam retains the beneficial effects of higher dose propofol, but in contrast, most patients are only moderately sedated.
VOLUME 59, NO. 5, 2004
*S1563 A Prospective Randomised Single Blind Comparison of Three Methods of Bowel Preparation for Out-patient Flexible Sigmoidoscopy Anand L. Gidwani, Ragai R. Makar, Daphne Garrett, Robert Gilliland Introduction: Flexible Sigmoidoscopy is becoming the minimum standard for the investigation of colorectal symptoms. Preparation for out-patient sigmoidoscopy using one self-administered phosphate enema is the standard practice in our unit but provides acceptable bowel preparation in only 80% of patients. This study compared two methods of bowel preparation with the current standard in an attempt to improve efficacy and acceptability. Methods: From JanuarySeptember 2003, patients attending for out-patient flexible sigmoidoscopy were randomised to three groups: - Group 1: One Fleet enema two hours pre-procedure; Group 2: Two Fleet enemas, one on the evening prior to sigmoidoscopy and one two hours pre-procedure; Group 3: Lactulose 30mls orally 48 and 24 hours prior to sigmoidoscopy plus a single Fleet enema two hours pre-procedure. A patient questionnaire was used to assess side effects and tolerance. Endoscopists, who were blinded to the preparation used, completed questionnaires regarding procedure indication, preparation quality (excellent, good, fair, poor), depth of insertion, and findings. Power calculations were based on the 80% acceptable preparation rate obtained by using a single enema. An 80% probability of detecting a 10% difference in the quality of bowel preparation required a minimum of 70 patients per group. Results: 261 patients (Group 1: n=105; Group 2:n=81; Group 3:n=75) were included; endoscopist data was obtained in 96%. No difference was noted between the groups with regards age, gender, procedure indication, or grade of endoscopist. There was no difference between the groups in any of the patient acceptability variables examined (see table). There was no difference in the quality of preparation of patients in Group 1 vs. Group 2 (p=0.392) or Group 1 vs. Group 3 (p=0.132). However, lactulose + Fleet resulted in significantly fewer patients with acceptable preparation compared with two Fleet enemas (p=0.022). There was no difference between the groups in terms of depth of insertion or abnormalities noted. Conclusions: The addition of a Fleet enema or oral lactulose over and above a single fleet enema gives no significant improvement in the acceptability or efficacy of bowel preparation. 1 Chi-squared; 2 Fishers exact
GASTROINTESTINAL ENDOSCOPY
P127