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Completed

NCT Number: NCT03141697

The Use of CO2 in 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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Leipzig

Leipzig, 04103, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Carbon Dioxide

Device

Insufflation of Carbon Dioxide

room air

Device

Insufflation of room air

Primary outcomes

  1. Post-procedural pain

    Time frame: 0 - 24 hrs after colonoscopy

    Pain after Colonoscopy, assessed by visual analog scale (VAS)

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Leipzig

Other

Registry information

Official study title

Is CO2 Insufflation an Amelioration of Routine Colonoscopy?

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
May 5, 2017
Registry last updated
May 5, 2017

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.

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