CO2 Versus O2 Insufflation During ERCP Depending on Sedation Protocols

Completed

• Conditions: Satisfaction; Complication

• Registration Number: NCT01761474
• Lead Sponsor: Soon Chun Hyang University

Brief Summary

Endoscopic retrograde cholangiopancreatography(ERCP) and related procedures can cause abdominal pain and discomfort. Some clinical trials have indicated, using the visual analogue scale (VAS) score, that CO2 insufflation during ERCP ameliorates the suffering of patients without complications, compared with air insufflation. However, differences in patient suffering between CO2 and air insufflation after ERCP depending on sedation protocols have not been reported. We therefore planned prospective, double-blind, randomized, controlled study with CO2 and air insufflation during ERCP depending on sedation protocol.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-20
• Study First Submitted QC: 2013-01-03
• Study First Posted: 2013-01-04
• Primary Completion: 2013-06
• Study Completion: 2013-09
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-17
• Last Update Posted: 2014-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

• candidates for therapeutic ERCP

Exclusion Criteria

• age<18 years
• pregnant women
• total gastrectomy
• uncontrolled coagulopathy
• American Society of Anesthesiologist(ASA) Class V
• neurologic impairment
• known allergy to the drugs used
• history of complications with previous sedation, sedative
• alcohol abuse
• inability to provide informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sedation quality	After patients' alertness (at least 10 minutes later), 3 hrs, and 24 hrs later	Abdominal pain, discomfort, and gas accumulation

Secondary Outcome Measures

Name	Time	Method
Procedure outcome	After completion of procedure, within 2hrs	1. Technical success or fail of procedure; 2. Procedure quality and satisfaction to patients and endoscopist
Complications	After completion of procedures (within 2 hrs) and 24 hrs later	Procedure related complications; pancreatitis, bleeding, cholangitis, or perforation

Trial Locations

Locations (1)

Soon Chun Hyang University Cheonan Hospital; 🇰🇷 Cheonan, Chungchungnam-do, Korea, Republic of