Status:
TERMINATED
Safety Study of Colonoscopy Under Sedation
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Colonoscopy Procedure
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
The aim of this study was to compare the analgesia provided by nitrous oxide/oxygen sedation or general anesthesia for colonoscopy
Detailed Description
The purpose of this protocol is to compare two methods of analgesia/sedation for colonoscopy. Sedation and analgesia induced by a 50% nitrous oxide/oxygen mixture could sufficient to allow the practic...
Eligibility Criteria
Inclusion
- Patient referred for colonoscopy with general anesthesia
- Age above 18 et below 75 year
- Patient who gave an informed consent
Exclusion
- Age below 18 ou above 75
- Need for gastroscopy in the same procedure than colonoscopy
- History of surgery wih resection more extended than half of the colon
- Dementia with autonomy loss or psychiatric disorder non controlled by therapeutic
- Severe congestive heart failure or evolutive heart ischemia
- Recent cerebral stroke
- Hemodynamic instability
- Respiratory failure, severe chronic obstructive pulmonary (including asthma) or progressive pneumothorax
- Hepatic failure (Child-Pugh score\> 9)
- Terminal renal failure 11 Hematopoietic disorders
- 12\. Pathology with expected survival shorter than the duration of the study and cancer excepted basal cell carcinoma of the skin 13. Alcohol consumption higher than 100 gr per day 14. Pregnancy or breastfeeding at the inclusion period
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT00930358
Start Date
February 1 2009
End Date
January 1 2011
Last Update
April 6 2011
Active Locations (1)
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1
Hotel Dieu Hospital
Paris, France, 75004