The Use of CO2 in Routine-Colonoscopy

Not Applicable

Completed

• Conditions: Colonoscopy

• Registration Number: NCT03141697
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-04-01
• Primary Completion: 2014-08-31
• Study Completion: 2014-08-31
• Study First Submitted: 2017-04-26
• Status Verified: 2017-05
• Study First Submitted QC: 2017-05-04
• Last Update Submitted: 2017-05-04
• Study First Posted: 2017-05-05
• Last Update Posted: 2017-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Post-procedural pain	0 - 24 hrs after colonoscopy	Pain after Colonoscopy, assessed by visual analog scale (VAS)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Leipzig; 🇩🇪 Leipzig, Germany