Safety Study of Colonoscopy Under Sedation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2011-01-31

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

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Pain

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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.

Conditions

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Colonoscopy Procedure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MEOPA

MEOPA : equimolar nitrous oxide/oxygen mixture

Group Type EXPERIMENTAL

MEOPA

Intervention Type DRUG

anaesthetic gaz inhalation

General anesthesia

Gold standard

Group Type ACTIVE_COMPARATOR

general anaesthesia

Intervention Type DRUG

Anaesthetic intravenous route

Interventions

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MEOPA

anaesthetic gaz inhalation

Intervention Type DRUG

general anaesthesia

Anaesthetic intravenous route

Intervention Type DRUG

Other Intervention Names

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anaesthetic gaz inhalation Anaesthetic intravenous route

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No