The Use of CO2 in Routine-Colonoscopy

May 4, 2017 updated by: Juergen Feisthammel, University of Leipzig

Is CO2 Insufflation an Amelioration of Routine Colonoscopy?

In this double-blind, randomised and controlled study 150 Patients referred to colonoscopy were assigned to either CO2 or air insufflation. We recorded basic characteristics of colonoscopy and the amount of drugs used for sedation. Patients and investigators filled out questionnaires to record pain, abdominal bloating and flatulence.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Between April 2012 and August 2014 150 patients referred to the University Hospital of Leipzig for colonoscopy were randomly assigned to either CO2 or air insufflation.

All examinations were performed by one of four experienced endoscopists. The patients usually received sedation. For sedation midazolam and propofol was used. At the beginning of the examination the patients usually received between 3-5 mg of midazolam and 20-40 mg propofol. During endoscopy propofol was titrated by administration of 20 mg at the time according to and pain reaction of the patient and required depth of sedation.

All patients had nasal insufflation of oxygen with 2 litres per minute. All sedated patients were monitored for pulse, blood pressure and blood oxygen saturation.

For bowel cleansing a solution of Macrogol 3350 (Moviprep®, Norgine) was administered orally according to the manufacturer.

All colonoscopies were performed using Fujifilm Endoscopes (EC 590 Series). For examinations with use of carbon dioxide the Fujifilm CO2 Insufflator GW-1 was used with appropriate water bottle and endoscope valve. The air pump of the light source Fujifilm System 4400 was deactivated according to the manufacturer.

Study Type

Interventional

Enrollment (Actual)

150

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

  • Germany
      • Leipzig, Germany, 04103
        • University of Leipzig

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • older than 18 years
  • informed consent

Exclusion Criteria:

  • former colonic resections
  • severe heart or lung disease (NYHA III or IV)
  • Pregnancy
  • Patients with planned gastroscopy within 24 hours

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Carbon Dioxide
Colonoscopy with Insufflation of Carbon Dioxide
Device: Carbon Dioxide
Insufflation of Carbon Dioxide
Placebo Comparator: Room Air
Colonoscopy with Insufflatioin of Room Air
Device: Room air
Insufflation of room air

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-procedural pain
Time Frame: 0 - 24 hrs after colonoscopy
Pain after Colonoscopy, assessed by visual analog scale (VAS)
0 - 24 hrs after colonoscopy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abdominal bloating
Time Frame: 0 - 24 hrs after colonoscopy
Abdominal bloating, assessed by questionaire
0 - 24 hrs after colonoscopy
flatulence
Time Frame: 0 - 24 hrs after colonoscopy
flatulence, assessed by questionaire
0 - 24 hrs after colonoscopy
procedure time
Time Frame: duration of colonoscopy
time used for colonoscopy
duration of colonoscopy
Used amount of sedative drugs
Time Frame: during endoscopy
Amount of midazolam and propofol administrated during colonoscopy
during endoscopy

Collaborators and Investigators

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

Sponsor

University of Leipzig

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 (Actual)

April 1, 2012

Primary Completion (Actual)

August 31, 2014

Study Completion (Actual)

August 31, 2014

Study Registration Dates

First Submitted

April 26, 2017

First Submitted That Met QC Criteria

May 4, 2017

First Posted (Actual)

May 5, 2017

Study Record Updates

Last Update Posted (Actual)

May 5, 2017

Last Update Submitted That Met QC Criteria

May 4, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CO2 Colonoscopy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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