L Laluna1, M L Allen, A J Dimarino. 1. Division of Gastroenterology and Hepatology, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania 19107, USA.
Abstract
BACKGROUND: Whether an opiate-benzodiazepine combination is superior to benzodiazepine alone for sedation in upper endoscopy is controversial. The purpose of this study was to compare the effectiveness of intravenous midazolam alone versus the combination of intravenous midazolam and intravenous meperidine for the sedation of patients undergoing upper endoscopy. METHODS:One hundred seven patients scheduled for outpatient diagnostic esophagogastroduodenoscopy were randomly assigned to receive 50 mg intravenous meperidine (53 of 107) or placebo (54 of 107). All patients received topical lidocaine spray and as much midazolam as the endoscopist thought the patient needed. Patients and endoscopists were blinded as to assignment. Data collected included intubation time (seconds), procedure time (minutes), pulse, blood pressure, complications, and the need for reversal agents. The endoscopist evaluated the quality of sedation immediately after the procedure (1 = excellent, 2 = good, 3 = fair, and 4 = poor). The patient evaluated the procedure the next day by phone (1 = no discomfort or did not remember, 2 = slightly uncomfortable, 3 = extremely uncomfortable, and 4 = unacceptable). Patients were also asked whether they would agree to another esophagogastroduodenoscopy if their doctor thought it was medically necessary. RESULTS: The intubation time, procedure time and blood pressure were not significantly different between the 2 groups. In comparing the meperidine group versus placebo group, the highest pulse (82.3 vs. 93.7, p = 0.0010), lowest pulse (67.2 vs. 72.3, p = 0.0194) and amount of midazolam used (4.0 vs. 4.8 mg, p = 0.0185 or 0.53 vs. 0.67 mg/kg, p = 0.0083) were significantly different by using a t test analysis. Patient evaluations comparing meperidine versus placebo showed responses of 1 (52 vs. 49), 2 (1 vs. 3), 3 (0 vs. 2) and 4 (0 vs. 0), which were not significantly different. The endoscopists'evaluation comparing meperidine versus placebo gave responses of excellent (44 vs. 27), good (6 vs. 22), fair (3 vs. 5) and poor (0 vs. 0), which were highly significantly different (p < 0.001) by using chi-square statistical techniques. CONCLUSION: The addition of meperidine to midazolam in sedating patients undergoing upper endoscopy adds no benefit from the patient viewpoint, whereas endoscopists favored the use of both medications.
RCT Entities:
BACKGROUND: Whether an opiate-benzodiazepine combination is superior to benzodiazepine alone for sedation in upper endoscopy is controversial. The purpose of this study was to compare the effectiveness of intravenous midazolam alone versus the combination of intravenous midazolam and intravenous meperidine for the sedation of patients undergoing upper endoscopy. METHODS: One hundred seven patients scheduled for outpatient diagnostic esophagogastroduodenoscopy were randomly assigned to receive 50 mg intravenous meperidine (53 of 107) or placebo (54 of 107). All patients received topical lidocaine spray and as much midazolam as the endoscopist thought the patient needed. Patients and endoscopists were blinded as to assignment. Data collected included intubation time (seconds), procedure time (minutes), pulse, blood pressure, complications, and the need for reversal agents. The endoscopist evaluated the quality of sedation immediately after the procedure (1 = excellent, 2 = good, 3 = fair, and 4 = poor). The patient evaluated the procedure the next day by phone (1 = no discomfort or did not remember, 2 = slightly uncomfortable, 3 = extremely uncomfortable, and 4 = unacceptable). Patients were also asked whether they would agree to another esophagogastroduodenoscopy if their doctor thought it was medically necessary. RESULTS: The intubation time, procedure time and blood pressure were not significantly different between the 2 groups. In comparing the meperidine group versus placebo group, the highest pulse (82.3 vs. 93.7, p = 0.0010), lowest pulse (67.2 vs. 72.3, p = 0.0194) and amount of midazolam used (4.0 vs. 4.8 mg, p = 0.0185 or 0.53 vs. 0.67 mg/kg, p = 0.0083) were significantly different by using a t test analysis. Patient evaluations comparing meperidine versus placebo showed responses of 1 (52 vs. 49), 2 (1 vs. 3), 3 (0 vs. 2) and 4 (0 vs. 0), which were not significantly different. The endoscopists'evaluation comparing meperidine versus placebo gave responses of excellent (44 vs. 27), good (6 vs. 22), fair (3 vs. 5) and poor (0 vs. 0), which were highly significantly different (p < 0.001) by using chi-square statistical techniques. CONCLUSION: The addition of meperidine to midazolam in sedating patients undergoing upper endoscopy adds no benefit from the patient viewpoint, whereas endoscopists favored the use of both medications.
Authors: Khurram J Khan; Houssein Fergani; Subhas C Ganguli; Subash Jalali; Robert Spaziani; Keith Tsoi; David G Morgan Journal: J Can Assoc Gastroenterol Date: 2018-08-09