Safety Study of Colonoscopy Under Sedation

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00930358
• Date of registration: 29/06/2009
• Prospective Registration: No
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: Safety Study of Colonoscopy Under Sedation KALINAG
• Scientific title: Tolerance and Acceptability of Colonoscopy Under Sedation by an Equimolar Mixture of Oxygen and Nitrous Oxide. Comparison With General Anesthesia in a Randomized, Multicentric Study.
• Date of first enrolment: February 2009
• Target sample size: 220
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00930358
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

France

Contacts

• Name: Dominique Lamarque, MD, PhD
• Affiliation: Assistance Publique - Hôpitaux de Paris

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Patient referred for colonoscopy with general anesthesia

2. Age above 18 et below 75 year

3. Patient who gave an informed consent

Exclusion Criteria:

1. Age below 18 ou above 75

2. Need for gastroscopy in the same procedure than colonoscopy

3. History of surgery wih resection more extended than half of the colon

4. Dementia with autonomy loss or psychiatric disorder non controlled by therapeutic

5. Severe congestive heart failure or evolutive heart ischemia

6. Recent cerebral stroke

7. Hemodynamic instability

8. Respiratory failure, severe chronic obstructive pulmonary (including asthma) or
progressive pneumothorax

9. Hepatic failure (Child-Pugh score> 9)

10. 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Colonoscopy Procedure

Intervention(s)

Drug: general anaesthesia

Drug: MEOPA

Primary Outcome(s)

Percentage of patients who have well tolerated the colonoscopy as assessed by visual analogic scale (>75/100) [Time Frame: Immediately after the colonoscopy]

The mean grade of patient anxiety before endoscopy [Time Frame: After the colonoscopy]

Secondary Outcome(s)

The mean pain intensity during the procedure on a visual analogic scale [Time Frame: after the colonoscopy]

The mean tolerability of the colonoscopy between the group with sedation by nitrous oxide/oxygen mixture and the group with anesthesia [Time Frame: after the colonoscopy]

The Aldrete's score at the hospital discharge [Time Frame: After the colonoscopy]

The mean patient satisfaction on a visual analogic scale. [Time Frame: after the colonoscopy]

The grade of difficulty of the colonoscopy evaluated by the endoscopist [Time Frame: After the colonoscopy]

The percentage of ileal intubation [Time Frame: After the colonoscopy]

The time to hospital discharge [Time Frame: After the issue of the colonoscopy]

The number of patient who have refused the inclusion [Time Frame: After the issue of the colonoscopy]

The opinion of the endoscopist on the tolerance of the colonoscopy [Time Frame: After the colonoscopy]

The percentage of caecum intubation [Time Frame: After the colonoscopy]

The percentage of patients who agree to repeat the procedure in similar circumstances. [Time Frame: after the colonoscopy]

The mean duration of the endoscopy [Time Frame: After the colonoscopy]

Secondary ID(s)

P060240

Source(s) of Monetary Support

Please refer to primary and secondary sponsors