CO2 Versus O2 Insufflation During ERCP Depending on Sedation Protocols

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.

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Key information

Conditions

Satisfaction Behavior Complication Personal Satisfaction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Soon Chun Hyang University Cheonan Hospital

Cheonan, Chungchungnam-do, 330-721, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Sedation quality

Time frame: After patients' alertness (at least 10 minutes later), 3 hrs, and 24 hrs later

Abdominal pain, discomfort, and gas accumulation

Secondary outcomes

Complications

Time frame: After completion of procedures (within 2 hrs) and 24 hrs later

Procedure related complications; pancreatitis, bleeding, cholangitis, or perforation
Procedure outcome

Time frame: After completion of procedure, within 2hrs
- Technical success or fail of procedure
- Procedure quality and satisfaction to patients and endoscopist

Sponsors and collaborators

Lead sponsor

Soon Chun Hyang University

Other

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Jan 4, 2013
Registry last updated: Mar 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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