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Trial record 19 of 2410 for:    CARBON DIOXIDE

The Use of CO2 in Routine-Colonoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03141697
Recruitment Status : Completed
First Posted : May 5, 2017
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):
Juergen Feisthammel, University of Leipzig

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Colonoscopy Device: Carbon Dioxide Device: Room air Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic
Official Title: Is CO2 Insufflation an Amelioration of Routine Colonoscopy?
Actual Study Start Date : April 1, 2012
Actual Primary Completion Date : August 31, 2014
Actual Study Completion Date : August 31, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

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




Primary Outcome Measures :
  1. Post-procedural pain [ Time Frame: 0 - 24 hrs after colonoscopy ]
    Pain after Colonoscopy, assessed by visual analog scale (VAS)


Secondary Outcome Measures :
  1. Abdominal bloating [ Time Frame: 0 - 24 hrs after colonoscopy ]
    Abdominal bloating, assessed by questionaire

  2. flatulence [ Time Frame: 0 - 24 hrs after colonoscopy ]
    flatulence, assessed by questionaire

  3. procedure time [ Time Frame: duration of colonoscopy ]
    time used for colonoscopy

  4. Used amount of sedative drugs [ Time Frame: during endoscopy ]
    Amount of midazolam and propofol administrated during colonoscopy



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03141697


Locations
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Germany
University of Leipzig
Leipzig, Germany, 04103
Sponsors and Collaborators
University of Leipzig

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Responsible Party: Juergen Feisthammel, Medical Doctor, Principal Investigator, University of Leipzig
ClinicalTrials.gov Identifier: NCT03141697     History of Changes
Other Study ID Numbers: CO2 Colonoscopy
First Posted: May 5, 2017    Key Record Dates
Last Update Posted: May 5, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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

Keywords provided by Juergen Feisthammel, University of Leipzig:
Carbon Dioxide
Coloboscopy