Randomized Controlled Trial Comparing Co2 vs. Air in Colonoscopy in Sedated Patients

April 16, 2008 updated by: Medical University of Vienna

CO2 insufflation instead of air for colonic distension in colonoscopy is considered to reduce pain after and during colonoscopy. There is limited data, that Co2 is similar effective in sedated patients. Furthermore it had not been investigated if patient's compliance for participating in cancer screening could be improved by using Co2.

The aim of the study is to assess postoperative pain and satisfaction after colonoscopy by comparing C02 with air.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1230
        • Recruiting
        • Dr. Anton Friedrich Weiser
        • Contact:
        • Principal Investigator:
          • Stefan Riss, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients, who are assigned to an outdoor ambulance for elective colonoscopy in sedation
  • Between 18 and 90 years

Exclusion Criteria:

  • COPD
  • Dementia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 2
Air insufflation in colonoscopy
Other: Air insufflation use in colonoscopy
Air insufflation for colonic distension
Other: 1
CO2 insufflation in colonoscopy
Other: CO2 use in colonoscopy
Co2 insufflation for colonic distension

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain after Colonoscopy measured by 100mm visual analogue scale.
Time Frame: 15 and 30 minutes and 6 h and 12 h after colonoscopy
15 and 30 minutes and 6 h and 12 h after colonoscopy

Secondary Outcome Measures

Outcome Measure
Time Frame
patients satisfaction (VAS) and its benefit in regard to cancer screening (2 questions)
Time Frame: 30 minutes and 6 hours after colonoscopy
30 minutes and 6 hours after colonoscopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Stefan Riss, MD, Medical University of Vienna
  • Principal Investigator: Anton Weiser, MD, Ärztezentrum Ost, Anton Baumgartnerstrasse 44, 1230 Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Anticipated)

October 1, 2008

Study Completion (Anticipated)

October 1, 2008

Study Registration Dates

First Submitted

April 14, 2008

First Submitted That Met QC Criteria

April 16, 2008

First Posted (Estimate)

April 17, 2008

Study Record Updates

Last Update Posted (Estimate)

April 17, 2008

Last Update Submitted That Met QC Criteria

April 16, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EK 07-238-VK

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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