NCT01709422

Efficacy and Safety Profiles of Combination Sedation Propofol With Midazolam and Meperidine.

Efficacy and Safety Profiles of Sedation With Propofol Combined With Intravenous Midazolam and Meperidine Versus Intravenous Midazolam and Meperidine for Ambulatory Endoscopic Retrograde-cholangiopancreatography(ERCP).

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Prince of Songkla University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare efficacy and safety of combination of propofol and midazolam with meperidine versus midazolam and meperidine for ambulatory ERCP

Detailed description

ERCP is commonly done under sedation with midazolam and meperidine, however some studies showed varying outcomes of this conventional sedation for maintained sedation. Propofol is increasing used for sedation in gastrointestinal procedure owing to its rapid recovery profiles but the complications associated with propofol are not negligible.The investigators prospectively compare the efficacy, induction time, recovery time, patient satisfaction and side effect between propofol based and conventional sedations in patients undergoing ERCP.

Conditions

• Disorders of Gallbladder, Biliary Tract and Pancrease

Interventions

Type	Name	Description
DRUG	Propofol	Propofol is the sedative drug used as an additional sedation to one of the study arm.
DRUG	Midazolam	Midazolam is one of the two conventional sedative drugs included in both arms.
DRUG	Meperidine	Meperidine is one of the two conventional sedative drugs included in both arms.

Timeline

• Start date: 2010-06-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2012-10-18
• Last updated: 2013-10-22
• Results posted: 2013-08-27

Locations

1 site across 1 country: Thailand