NCT01540084

Cocktail Sedation Containing Propofol Versus Conventional Sedation for Endoscopic Retrograde Cholangiopancreatography (ERCP)

Cocktail Sedation Containing Propofol Versus Conventional Sedation for ERCP: a Prospective, Randomized Controlled Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 205 (actual)
• Sponsor: King Chulalongkorn Memorial Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Endoscopic retrograde cholangiopancreatography (ERCP) practically requires moderate to deep sedation by a combination of benzodiazepine and opioid. Propofol as a sole agent may cause oversedation. A combination (cocktail) of infused propofol, meperidine, and midazolam can reduce the dosage of propofol and may result in a lower risk of oversedation. The investigators prospectively compare the efficacy, recovery time, patient satisfactory, and side effects between cocktail and conventional sedations in patients undergoing ERCP.

Detailed description

ERCP patients were prospectively randomized into 2 groups; the cocktail group and the controls. For induction, a combination of 25 mg of meperidine and 2.5 mg of midazolam were injected in both groups. In the cocktail group, a bolus dose of propofol 1 mg/kg was administered and continuously infused. In the controls, 25 mg of meperidine or 2.5 mg/kg of midazolam were titrated to maintain the level of sedation.

Conditions

• Disorders of Gallbladder, Biliary Tract and Pancreas

Interventions

Type	Name	Description
DRUG	propofol	For induction, 25 mg of meperidine and 2.5 mg of midazolam were administered in both groups. In the cocktail group, one milligram per kilogram body weight of 1% propofol emulsion (Baxter Healthcare Corp., Irvine, CA) was slowly infused by an automated pump (Terufusion syringe pump TE-331, Terumo Corporation, Tokyo, Japan). To maintain conscious level of patient in the conventional group to be at moderate or deep level, 25 mg of meperidine and/or 2.5 mg of midazolam were administered as necessary, whereas patients in the cocktail group were continuously administered with 1% propofol at the rate of 1 mg/kg/hr. An additional 0.5 mg/kg bolus was administered as needed to achieve the designed conscious level.

Timeline

• Start date: 2006-12-01
• Primary completion: 2009-08-01
• Completion: 2009-12-01
• First posted: 2012-02-28
• Last updated: 2012-02-28

Locations

1 site across 1 country: Thailand