The Use of CO2 in Routine-Colonoscopy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Is CO2 Insufflation an Amelioration of Routine Colonoscopy?

Conditions
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Colonoscopy

Intervention / Treatment
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* Device: Carbon Dioxide
* Device: Room air


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carbon Dioxide<br>Colonoscopy with Insufflation of Carbon Dioxide | Device: Carbon Dioxide<br>* Insufflation of Carbon Dioxide<br>|
| Placebo Comparator: Room Air<br>Colonoscopy with Insufflatioin of Room Air | Device: Room air<br>* Insufflation of room air<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coloboscopy, Carbon Dioxide