The Use of CO2 in Routine-Colonoscopy

Colonoscopy Clinical Trial

Official title:

Is CO2 Insufflation an Amelioration of Routine Colonoscopy?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03141697
• Other study ID #: CO2 Colonoscopy
• Status: Completed
• Phase: N/A
• First received: April 26, 2017
• Last updated: May 4, 2017
• Start date: April 1, 2012
• Est. completion date: August 31, 2014

Study information

• Verified date: May 2017
• Source: University of Leipzig
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: August 31, 2014
• Est. primary completion date: August 31, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colonoscopy

Intervention

Device:
• Carbon Dioxide
Insufflation of Carbon Dioxide
• Room air
Insufflation of room air

Locations

Country	Name	City	State
Germany	University of Leipzig	Leipzig

Sponsors (1)

Lead Sponsor	Collaborator
University of Leipzig

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-procedural pain	Pain after Colonoscopy, assessed by visual analog scale (VAS)	0 - 24 hrs after colonoscopy
Secondary	Abdominal bloating	Abdominal bloating, assessed by questionaire	0 - 24 hrs after colonoscopy
Secondary	flatulence	flatulence, assessed by questionaire	0 - 24 hrs after colonoscopy
Secondary	procedure time	time used for colonoscopy	duration of colonoscopy
Secondary	Used amount of sedative drugs	Amount of midazolam and propofol administrated during colonoscopy	during endoscopy