CO2 Versus O2 Insufflation During ERCP Depending on Sedation Protocols

NCT01761474 | Completed

• 1 other identifier: ERCP-Sedation
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Satisfaction; Complication

Keywords

Carbon dioxide insufflation; Air insufflatioin; ERCP; Sedation

Outcome Measures

Primary Outcomes (1)

• Sedation quality

  Abdominal pain, discomfort, and gas accumulation

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

Secondary Outcomes (2)

• Complications

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

• Procedure outcome

  After completion of procedure, within 2hrs

Study Arms (4)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• candidates for therapeutic ERCP

You may not qualify if:

• 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

Sponsors & Collaborators

• Soon Chun Hyang University: lead

Study Sites (1)

Soon Chun Hyang University Cheonan Hospital

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

Location

MeSH Terms

Conditions

Personal Satisfaction

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Tae Hoon Lee, PhD

  SoonChunHyang University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 20, 2012
• First Posted: January 4, 2013
• Study Start: December 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: September 1, 2013
• Last Updated: March 19, 2014

Record last verified: 2014-03

Locations

KR (1)