Background/aims: Safety concerns have been raised about the use of the combination of an opioid and benzodiazepine for esophagogastroduodenoscopy (EGD) sedation, a common practice of American gastroenterologists. If we could show that patients in American practice settings satisfactorily tolerate EGD with midazolam alone, as is commonly done in Europe, it would provide impetus for American gastroenterologists to change practice habits.
Methods: We performed a randomized, double-blind trial to determine whether meperidine, used in addition to midazolam, improved patient tolerance to EGD compared with the use of midazolam alone in our academic practice setting. Safety parameters were also examined. One hundred twenty adult patients undergoing diagnostic EGD were randomized to receive either 50 mg of meperidine (group I) or 1 mg of midazolam (group II). Patients were then given additional midazolam in incremental doses at the discretion of the attending gastroenterologist to induce a state of conscious sedation.
Results: Including the study drug, patients in group I received an average of 1.8 mg less of midazolam compared with group II (mean total midazolam dose, 3.8 mg vs 5.6 mg; p = 0.037). Patients in group I showed improved tolerance for EGD compared with those in group II in terms of a physician rating of "poor" for the overall adequacy of sedation (7 vs 20%, p = 0.033), the need for supplemental narcotics or droperidol during the procedure (7 vs 20%, p = 0.033), the need for additional medication during intubation of the esophagus (12 vs 25%, p = 0.06), the need for a faculty member to accomplish esophageal intubation (7 vs 20%, p = 0.051), the presence of retching, which interfered with the procedure (21 vs 39%, p = 0.046), and premature termination of the exam (0 vs 7%, p = 0.055). No difference was seen in the degree of amnesia, in the willingness of patients to undergo another EGD in the future, or in cardiorespiratory parameters.
Conclusions: In our academic practice setting, 50 mg of meperidine given i.v. at the start of the procedure improved the ability of our patients to tolerate EGD from the endoscopists' standpoint. We found no difference in cardiorespiratory parameters between the groups.