Safety Study of Colonoscopy Under Sedation

Phase 4

Terminated

• Conditions: Colonoscopy Procedure
• Interventions: Drug: MEOPA; Drug: general anaesthesia

• Registration Number: NCT00930358
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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 practice of colonoscopy instead of general anesthesia which is accompanied with certain risks and post procedure drowsiness.

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-06-29
• Study First Submitted QC: 2009-06-29
• Study First Posted: 2009-06-30
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-05
• Last Update Posted: 2011-04-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 220

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

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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

11. 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MEOPA	MEOPA	MEOPA : equimolar nitrous oxide/oxygen mixture
General anesthesia	general anaesthesia	Gold standard

Primary Outcome Measures

Name	Time	Method
Percentage of patients who have well tolerated the colonoscopy as assessed by visual analogic scale (>75/100)	Immediately after the colonoscopy
The mean grade of patient anxiety before endoscopy	After the colonoscopy	The mean grade of patient anxiety before endoscopy

Secondary Outcome Measures

Name	Time	Method
The mean tolerability of the colonoscopy between the group with sedation by nitrous oxide/oxygen mixture and the group with anesthesia	after the colonoscopy
The mean pain intensity during the procedure on a visual analogic scale	after the colonoscopy
The mean patient satisfaction on a visual analogic scale.	after the colonoscopy
The percentage of patients who agree to repeat the procedure in similar circumstances.	after the colonoscopy
The grade of difficulty of the colonoscopy evaluated by the endoscopist	After the colonoscopy
The mean duration of the endoscopy	After the colonoscopy
The percentage of caecum intubation	After the colonoscopy
The percentage of ileal intubation	After the colonoscopy
The opinion of the endoscopist on the tolerance of the colonoscopy	After the colonoscopy
The time to hospital discharge	After the issue of the colonoscopy
The Aldrete's score at the hospital discharge	After the colonoscopy
The number of patient who have refused the inclusion	After the issue of the colonoscopy

Trial Locations

Locations (1)

Hotel Dieu Hospital; 🇫🇷 Paris, France