CO2 Versus O2 Insufflation During ERCP Depending on Sedation Protocols

Soon Chun Hyang University210 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

210

Conditions

Satisfaction Complication

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Soon Chun Hyang University Cheonan Hospital

Outcomes

Primary Outcomes

Sedation quality

Abdominal pain, discomfort, and gas accumulation

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

Secondary Outcomes

Complications

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

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

Procedure outcome

1. Technical success or fail of procedure 2. Procedure quality and satisfaction to patients and endoscopist

Time frame: After completion of procedure, within 2hrs