CO2 Versus O2 Insufflation During ERCP Depending on Sedation Protocols

Satisfaction Clinical Trial

Official title:

Carbon Dioxide Insufflations vs. Air Insufflation in Therapeutic ERCP: A Randomized Double-blind Comparative Study Depending on Sedation Methods

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01761474
• Other study ID #: ERCP-Sedation
• Status: Completed
• Phase: N/A
• First received: December 20, 2012
• Last updated: March 17, 2014
• Start date: December 2012
• Est. completion date: September 2013

Study information

• Verified date: March 2014
• Source: Soon Chun Hyang University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: September 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Complication
• Satisfaction

Locations

Country	Name	City	State
Korea, Republic of	Soon Chun Hyang University Cheonan Hospital	Cheonan	Chungchungnam-do

Sponsors (1)

Lead Sponsor	Collaborator
Soon Chun Hyang University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sedation quality	Abdominal pain, discomfort, and gas accumulation	After patients' alertness (at least 10 minutes later), 3 hrs, and 24 hrs later	No
Secondary	Complications	Procedure related complications; pancreatitis, bleeding, cholangitis, or perforation	After completion of procedures (within 2 hrs) and 24 hrs later	No
Secondary	Procedure outcome	Technical success or fail of procedure; Procedure quality and satisfaction to patients and endoscopist	After completion of procedure, within 2hrs	No