An interventional study of Carbon Dioxide and Room air in Colonoscopy, sponsored by University of Leipzig. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-05.
Sponsored by University of Leipzig · Not applicable, Interventional, and Diagnostic
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.
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.
University of Leipzig is the lead sponsor of 147 studies on the registry; 24 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Colonoscopy with Insufflation of Carbon Dioxide
Device: Carbon Dioxide
Colonoscopy with Insufflatioin of Room Air
Device: Room air
Insufflation of Carbon Dioxide
Insufflation of room air
Post-procedural pain
Pain after Colonoscopy, assessed by visual analog scale (VAS)
Time frame: 0 - 24 hrs after colonoscopy
Abdominal bloating
Abdominal bloating, assessed by questionaire
Time frame: 0 - 24 hrs after colonoscopy
flatulence
flatulence, assessed by questionaire
Time frame: 0 - 24 hrs after colonoscopy
procedure time
time used for colonoscopy
Time frame: duration of colonoscopy
Used amount of sedative drugs
Amount of midazolam and propofol administrated during colonoscopy
Time frame: during endoscopy
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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University of Leipzig