Outcome of Carbon Dioxide Versus Air Insufflations During Endoscopic Retrograde Cholangiopancreatography (ERCP)
To assess the safety and efficacy of CO2 insufflations during ERCP
To assess the patient's symptoms, abdominal pain and abdominal distension post procedure (ERCP) in the study group.
- Secondary objective:
- To assess the adequacy of bowel distension for adequate luminal visualization
- To assess the peristaltic movement during the ERCP
- 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.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||A Double-blind, Randomized, Controlled Trial of Air Insufflation Versus Carbon Dioxide Insufflation During Endoscopic Retrograde Cholangiopancreatography (ERCP).|
- Patient comfort post ERCP [ Time Frame: 1 hour ] [ Designated as safety issue: No ]the pain score measures using Visual Analog scale (VAs - 1 to 10 cm scale )
- Abdominal distention prior and post ERCP [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]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.
|Study Start Date:||August 2010|
|Study Completion Date:||March 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
|Group-A, use of air;|
|Group-B use of CO2|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01321203
|Asian Institute Of Gastroenterology India|
|Hyderabad, Andra Pradesh, India, 500082|
|Principal Investigator:||Saravanan Arjuanan, MD||Asian Institute of Gastroenterology, India|