The Use of CO2 in Routine-Colonoscopy

University of Leipzig

Status: Completed

Conditions: Colonoscopy

Treatments: Device: Room air; Device: Carbon Dioxide

Study type: Interventional

Funder types: Other

Identifiers

NCT03141697

CO2 Colonoscopy

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 2 patient groups, including a placebo group

Carbon Dioxide

Experimental group

Description:

Colonoscopy with Insufflation of Carbon Dioxide

Treatment:

Device: Carbon Dioxide

Room Air

Placebo Comparator group

Description:

Colonoscopy with Insufflatioin of Room Air

Treatment:

Device: Room air