The Use of CO2 in Routine-Colonoscopy
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|ClinicalTrials.gov Identifier: NCT03141697|
Recruitment Status : Completed
First Posted : May 5, 2017
Last Update Posted : May 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Colonoscopy||Device: Carbon Dioxide Device: Room air||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Is CO2 Insufflation an Amelioration of Routine Colonoscopy?|
|Actual Study Start Date :||April 1, 2012|
|Actual Primary Completion Date :||August 31, 2014|
|Actual Study Completion Date :||August 31, 2014|
Experimental: Carbon Dioxide
Colonoscopy with Insufflation of Carbon Dioxide
Device: Carbon Dioxide
Insufflation of Carbon Dioxide
Placebo Comparator: Room Air
Colonoscopy with Insufflatioin of Room Air
Device: Room air
Insufflation of room air
- Post-procedural pain [ Time Frame: 0 - 24 hrs after colonoscopy ]Pain after Colonoscopy, assessed by visual analog scale (VAS)
- Abdominal bloating [ Time Frame: 0 - 24 hrs after colonoscopy ]Abdominal bloating, assessed by questionaire
- flatulence [ Time Frame: 0 - 24 hrs after colonoscopy ]flatulence, assessed by questionaire
- procedure time [ Time Frame: duration of colonoscopy ]time used for colonoscopy
- Used amount of sedative drugs [ Time Frame: during endoscopy ]Amount of midazolam and propofol administrated during colonoscopy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03141697
|University of Leipzig|
|Leipzig, Germany, 04103|