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CO2 Versus O2 Insufflation During ERCP Depending on Sedation Protocols

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01761474
First Posted: January 4, 2013
Last Update Posted: March 19, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Tae Hoon Lee, Soon Chun Hyang University
  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 Tae Hoon Lee, 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 ]
    Abdominal pain, discomfort, and gas accumulation


Secondary Outcome Measures:
  • Complications [ Time Frame: After completion of procedures (within 2 hrs) and 24 hrs later ]
    Procedure related complications; pancreatitis, bleeding, cholangitis, or perforation

  • 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


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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Tae Hoon Lee, Professor, Soon Chun Hyang University
ClinicalTrials.gov Identifier: NCT01761474     History of Changes
Other Study ID Numbers: ERCP-Sedation
First Submitted: December 20, 2012
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

Additional relevant MeSH terms:
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics