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This study was stopped due to low inclusion
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MEOPA | Experimental | MEOPA : equimolar nitrous oxide/oxygen mixture |
|
| General anesthesia | Active Comparator | Gold standard |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEOPA | Drug | anaesthetic gaz inhalation |
|
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Dominique Lamarque, MD, PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hotel Dieu Hospital | Paris | 75004 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9083731 | Background | Trojan J, Saunders BP, Woloshynowych M, Debinsky HS, Williams CB. Immediate recovery of psychomotor function after patient-administered nitrous oxide/oxygen inhalation for colonoscopy. Endoscopy. 1997 Jan;29(1):17-22. doi: 10.1055/s-2007-1004055. |
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| ID | Term |
|---|---|
| C576493 | Meopa |
| D000768 | Anesthesia, General |
| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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| general anaesthesia | Drug | Anaesthetic intravenous route |
|
|
| 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 |