Clinical Trial: Outcome of Carbon Dioxide Versus Air Insufflations During Endoscopic Retrograde Cholangiopancreatography (ERCP)

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: A Double-blind, Randomized, Controlled Trial of Air Insufflation Versus Carbon Dioxide Insufflation During Endoscopic Retrograde Cholangiopancreatography (ERCP).

Brief Summary:

To assess the safety and efficacy of CO2 insufflations during ERCP

  1. Primary objective:

    To assess the patient's symptoms, abdominal pain and abdominal distension post procedure (ERCP) in the study group.

  2. Secondary objective:

Endoscopist:

  • To assess the adequacy of bowel distension for adequate luminal visualization
  • To assess the peristaltic movement during the ERCP

Anesthetist:

  • To measure the PCO2 level in patient post procedure.
  • To assess the amount of sedation required during the procedure.
  • To assess saturation and vital signs through out the procedure.
  • To assess requirement of buscopan.

Detailed Summary: mentioned in complete
Sponsor: Asian Institute of Gastroenterology, India

Current Primary Outcome: Patient comfort post ERCP [ Time Frame: 1 hour ]

the pain score measures using Visual Analog scale (VAs - 1 to 10 cm scale )


Original Primary Outcome: Same as current

Current Secondary Outcome: Abdominal distention prior and post ERCP [ Time Frame: 5 minutes ]

The abdominal girth was measured prior to patient shifted to ERCP table. The immdiately post ERCP the abdominal girth measured. A fixed point is marked at the umblical regiem to maintain the site of abdominal girth.


Original Secondary Outcome: Same as current

Information By: Asian Institute of Gastroenterology, India

Dates:
Date Received: January 28, 2011
Date Started: August 2010
Date Completion:
Last Updated: July 16, 2011
Last Verified: July 2011