CO2 Versus O2 Insufflation During ERCP Depending on Sedation Protocols

• ClinicalTrials.gov Identifier: NCT01761474
• Recruitment Status: Completed
• First Posted: January 4, 2013
• Last Update Posted: March 19, 2014
• Sponsor: Soon Chun Hyang University
• Information provided by (Responsible Party): Tae Hoon Lee, Soon Chun Hyang University

Study Description

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.

Condition or disease
Satisfaction; Complication

Study Design

• Study Type: Observational
• Actual Enrollment: 210 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Carbon Dioxide Insufflations vs. Air Insufflation in Therapeutic ERCP: A Randomized Double-blind Comparative Study Depending on Sedation Methods
• Study Start Date: December 2012
• Actual Primary Completion Date: June 2013
• Actual Study Completion Date: September 2013

Groups and Cohorts

Group/Cohort
1. Carbon dioxide insufflation with BPS; Both midazolam (0.05 mg/kg body weight; 1 mg if age[70 or ASA class III-IV) and fentanyl (50 lg; 25 lg if age[70 or ASA class III-IV) were given intravenously at the initiation of sedation. Thereafter, repeated doses of 10-20 mg propofol were administered to achieve a moderate level of sedation. Maintenance of sedation was also performed with repeated doses of 10-20 mg propofol.
2. Carbon dioxide insufflation with Propofol; Sedation was induced by intravenous bolus injection of propofol (0.5 mg/kg body weight; 10 mg if age[70 or ASA class III-IV), followed by repeated doses of 10-20 mg propofol to induce sedation. Repeated doses of 10-20 mg propofol were then administered to maintain adequate sedation, according to the desired sedation depth and patient risk profile.
3. Air insufflation with BPS; Both midazolam (0.05 mg/kg body weight; 1 mg if age[70 or ASA class III-IV) and fentanyl (50 lg; 25 lg if age[70 or ASA class III-IV) were given intravenously at the initiation of sedation. Thereafter, repeated doses of 10-20 mg propofol were administered to achieve a moderate level of sedation. Maintenance of sedation was also performed with repeated doses of 10-20 mg propofol.
4. Air insufflation with Propofol; Sedation was induced by intravenous bolus injection of propofol (0.5 mg/kg body weight; 10 mg if age[70 or ASA class III-IV), followed by repeated doses of 10-20 mg propofol to induce sedation. Repeated doses of 10-20 mg propofol were then administered to maintain adequate sedation, according to the desired sedation depth and patient risk profile.

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

The study had an 80% power to detect a 20% difference in PAIN score any two groups, assuming 2-sided tests at a 5% significance level.Assuming a 10 % dropout rate, 220 patients were needed.

Criteria

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

Contacts and Locations

Locations

Korea, Republic of

Soon Chun Hyang University Cheonan Hospital

Cheonan, Chungchungnam-do, Korea, Republic of, 330-721

Sponsors and Collaborators

Soon Chun Hyang University

Investigators

• Principal Investigator: Tae Hoon Lee, PhD; SoonChunHyang University School of Medicine

More Information

• Responsible Party: Tae Hoon Lee, Professor, Soon Chun Hyang University
• ClinicalTrials.gov Identifier: NCT01761474
• Other Study ID Numbers: ERCP-Sedation
• First Posted: January 4, 2013
• Last Update Posted: March 19, 2014
• Last Verified: March 2014

Keywords provided by Tae Hoon Lee, Soon Chun Hyang University:

Carbon dioxide insufflation; Air insufflatioin; ERCP; Sedation