CO2 Versus O2 Insufflation During ERCP Depending on Sedation Protocols

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01761474

Enrollment

210

Registered

2013-01-04

Start date

2012-12-31

Completion date

2013-09-30

Last updated

2014-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complication, Satisfaction

Keywords

Carbon dioxide insufflation, Air insufflatioin, ERCP, Sedation

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

South Korea

Outcome results