CO2 Versus O2 Insufflation During ERCP Depending on Sedation Protocols

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tae Hoon Lee, Soon Chun Hyang University
ClinicalTrials.gov Identifier:
NCT01761474
First received: December 20, 2012
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

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
Satisfaction
Complication

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Soon Chun Hyang University:

Primary Outcome Measures:
  • Sedation quality [ Time Frame: After patients' alertness (at least 10 minutes later), 3 hrs, and 24 hrs later ] [ Designated as safety issue: No ]
    Abdominal pain, discomfort, and gas accumulation


Secondary Outcome Measures:
  • Complications [ Time Frame: After completion of procedures (within 2 hrs) and 24 hrs later ] [ Designated as safety issue: No ]
    Procedure related complications; pancreatitis, bleeding, cholangitis, or perforation

  • Procedure outcome [ Time Frame: After completion of procedure, within 2hrs ] [ Designated as safety issue: No ]
    1. Technical success or fail of procedure
    2. Procedure quality and satisfaction to patients and endoscopist


Enrollment: 210
Study Start Date: December 2012
Study Completion Date: September 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01761474

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

No publications provided

Responsible Party: Tae Hoon Lee, Professor, Soon Chun Hyang University
ClinicalTrials.gov Identifier: NCT01761474     History of Changes
Other Study ID Numbers: ERCP-Sedation
Study First Received: December 20, 2012
Last Updated: March 17, 2014
Health Authority: Korea: Institutional Review Board

Keywords provided by Soon Chun Hyang University:
Carbon dioxide insufflation
Air insufflatioin
ERCP
Sedation

ClinicalTrials.gov processed this record on April 17, 2014