A RANDOMIZED, PROSPECTIVE, DOUBLE-BLIND COMPARISON OF MIDAZOLAM (VERSED) AND EMULSIFIED DIAZEPAM (DIZAC) FOR OPIOID-BASED, CONSCIOUS SEDATION IN ENDOSCOPIC PROCEDURES

Objective: We completed a prospective, randomized, double-blinded clin ical trial to compare the quality of sedation with two benzodiazepines (emulsified diazepam and midazolam) for endoscopic procedures, Method s: Adult: patients undergoing esophagogastroduodenoscopy of colonoscop y were eligible, Exclusion criteria included: drug allergies, altered mental status, untreated glaucoma, active pancreatitis, hyperlipidemia , resident physician training, or cases done outside the Endoscopy uni t, Nurses began the sedation process by administering an opioid follow ed immediately by administering study drugs until patients were adequa tely sedated, At completion of the procedure, both the physician and t he nurse rated whether the patient's sedation appeared to be adequate, In addition, before discharge, patients were asked to rate the qualit y of sedation, Results: A total of 111 patients were randomized to the emulsified diazepam group and 100 to the midazolam group, There was n o difference in the physician's assessment of quality of sedation betw een the groups (p > 0.05), The length of time Po sedation, total proce dure time, and recovery time were! similar between both groups, The es timated cost of using emulsified diazepam was approximately 50% less t han that of midazolam, with. an equal quality of sedation, Conclusion: Neither the physicians, nurses, nor tree patients could detect a diff erence between sedation produced by the drugs, We conclude that both d rugs were equally effective for sedation far both upper and lower endo scopic procedures, Based on the results of this trial, we suggest that increased use of emulsified diazepam would markedly reduce the Ease w ithout altering the quality of sedation, The cost savings would be at lease $50,000/yr at our institution, (C) 1998 by Am, Call, of Gastroen terology).