Clinical Trials Directory

Trials / Completed

CompletedNCT03141697

The Use of CO2 in Routine-Colonoscopy

Is CO2 Insufflation an Amelioration of Routine Colonoscopy?

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
150 (actual)
Sponsor
University of Leipzig · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICECarbon DioxideInsufflation of Carbon Dioxide
DEVICERoom airInsufflation of room air

Timeline

Start date
2012-04-01
Primary completion
2014-08-31
Completion
2014-08-31
First posted
2017-05-05
Last updated
2017-05-05

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT03141697. Inclusion in this directory is not an endorsement.