Safety Study of Colonoscopy Under Sedation

Study Overview
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Brief Summary
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The aim of this study was to compare the analgesia provided by nitrous oxide/oxygen sedation or general anesthesia for colonoscopy

Detailed Description
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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.

Official Title
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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.

Conditions
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Colonoscopy Procedure

Intervention / Treatment
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* Drug: MEOPA
* Drug: general anaesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient referred for colonoscopy with general anesthesia Age above 18 et below 75 year Patient who gave an informed consent Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MEOPA<br>MEOPA : equimolar nitrous oxide/oxygen mixture | Drug: MEOPA<br>* anaesthetic gaz inhalation<br>* Other names: anaesthetic gaz inhalation;|
| Active Comparator: General anesthesia<br>Gold standard | Drug: general anaesthesia<br>* Anaesthetic intravenous route<br>* Other names: Anaesthetic intravenous route;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | The mean grade of patient anxiety before endoscopy | After the colonoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sedation, Colonoscopy, General anesthesia