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

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.

Completed

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Key information

Conditions

Obstructive Jaundice Hyperbilirubinemia Jaundice Jaundice, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Asian Institute Of Gastroenterology India

Hyderabad, Andhra Pradesh, 500082, India

About this study

mentioned in complete

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All consecutive adult patients referred for ERCP to AIG Hyderabad

Exclusion criteria

Age < 18 years old excluded from the study.
Patients with COPD.
Patients with poor ejection fractions and decompensated heart failure.
Patients with acute illness that require emergency ERCP and not fit for pre procedure and post procedure assessments.
Patients with recent endoscopic procedure within 24 hours.
Patient with history of recent surgery within 7 days of duration.
Pregnant patients.
Patients not keen to give consent for the study.

Treatment and study plan

Primary outcomes

Patient comfort post ERCP

Time frame: 1 hour

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

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

Asian Institute of Gastroenterology, India

Other

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Mar 23, 2011
Registry last updated: Jul 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed