BACKGROUND:ERCP is often made difficult by duodenal motility. Glucagon is typically used to inhibit this motility. L-hyoscyamine is an antimuscarinic, anticholinergic agent shown to be a feasible intravenous alternative to glucagon. OBJECTIVE: Demonstrate whether pre-ERCPsublingual L-hyoscyamine reduces the amount of glucagon required to complete ERCP. DESIGN: Randomized, double-blinded clinical trial of 200 participants assigned to receiveL-hyoscyamine 0.5 mg or a placebo sublingually before ERCP. Comparative costs were determined. SETTING:Tertiary referral university hospital in the intermountain west. PATIENTS: Mix of inpatients and outpatients. MAIN OUTCOME MEASUREMENTS: The amount of supplemental glucagon required to complete ERCP was recorded, along with procedural outcomes and adverse effects. RESULTS: The 2 groups (101 L-hyoscyamine, 99 placebo) were equally matched in terms of patient and procedure characteristics. There was a decrease in the amount of glucagon required to complete ERCP in the L-hyoscyamine group versus the placebo group, but the reduction was not statistically significant. No differences in complication rates, procedural difficulty, success rates, adverse drug effects, or patient disposition existed between the L-hyoscyamine and placebo groups. LIMITATIONS: Procedures were performed by more than 1 endoscopist, and rescue glucagon was administered at the sole discretion of the endoscopist; this introduced variation in glucagon administered among the participants. CONCLUSIONS: Preprocedure administration of sublingual L-hyoscyamine did not reduce the amount of glucagon required to complete ERCP.
RCT Entities:
BACKGROUND: ERCP is often made difficult by duodenal motility. Glucagon is typically used to inhibit this motility. L-hyoscyamine is an antimuscarinic, anticholinergic agent shown to be a feasible intravenous alternative to glucagon. OBJECTIVE: Demonstrate whether pre-ERCP sublingual L-hyoscyamine reduces the amount of glucagon required to complete ERCP. DESIGN: Randomized, double-blinded clinical trial of 200 participants assigned to receive L-hyoscyamine 0.5 mg or a placebo sublingually before ERCP. Comparative costs were determined. SETTING: Tertiary referral university hospital in the intermountain west. PATIENTS: Mix of inpatients and outpatients. MAIN OUTCOME MEASUREMENTS: The amount of supplemental glucagon required to complete ERCP was recorded, along with procedural outcomes and adverse effects. RESULTS: The 2 groups (101 L-hyoscyamine, 99 placebo) were equally matched in terms of patient and procedure characteristics. There was a decrease in the amount of glucagon required to complete ERCP in the L-hyoscyamine group versus the placebo group, but the reduction was not statistically significant. No differences in complication rates, procedural difficulty, success rates, adverse drug effects, or patient disposition existed between the L-hyoscyamine and placebo groups. LIMITATIONS: Procedures were performed by more than 1 endoscopist, and rescue glucagon was administered at the sole discretion of the endoscopist; this introduced variation in glucagon administered among the participants. CONCLUSIONS: Preprocedure administration of sublingual L-hyoscyamine did not reduce the amount of glucagon required to complete ERCP.