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Safety Study of Colonoscopy Under Sedation (KALINAG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00930358
Recruitment Status : Terminated (This study was stopped due to low inclusion)
First Posted : June 30, 2009
Last Update Posted : April 6, 2011
Information provided by:
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

Condition or disease Intervention/treatment Phase
Colonoscopy Procedure Drug: MEOPA Drug: general anaesthesia Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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.
Study Start Date : February 2009
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
Experimental: MEOPA
MEOPA : equimolar nitrous oxide/oxygen mixture
anaesthetic gaz inhalation
Other Name: anaesthetic gaz inhalation

Active Comparator: General anesthesia
Gold standard
Drug: general anaesthesia
Anaesthetic intravenous route
Other Name: Anaesthetic intravenous route

Primary Outcome Measures :
  1. Percentage of patients who have well tolerated the colonoscopy as assessed by visual analogic scale (>75/100) [ Time Frame: Immediately after the colonoscopy ]
  2. The mean grade of patient anxiety before endoscopy [ Time Frame: After the colonoscopy ]
    The mean grade of patient anxiety before endoscopy

Secondary Outcome Measures :
  1. 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 ]
  2. The mean pain intensity during the procedure on a visual analogic scale [ Time Frame: after the colonoscopy ]
  3. The mean patient satisfaction on a visual analogic scale. [ Time Frame: after the colonoscopy ]
  4. The percentage of patients who agree to repeat the procedure in similar circumstances. [ Time Frame: after the colonoscopy ]
  5. The grade of difficulty of the colonoscopy evaluated by the endoscopist [ Time Frame: After the colonoscopy ]
  6. The mean duration of the endoscopy [ Time Frame: After the colonoscopy ]
  7. The percentage of caecum intubation [ Time Frame: After the colonoscopy ]
  8. The percentage of ileal intubation [ Time Frame: After the colonoscopy ]
  9. The opinion of the endoscopist on the tolerance of the colonoscopy [ Time Frame: After the colonoscopy ]
  10. The time to hospital discharge [ Time Frame: After the issue of the colonoscopy ]
  11. The Aldrete's score at the hospital discharge [ Time Frame: After the colonoscopy ]
  12. The number of patient who have refused the inclusion [ Time Frame: After the issue of the colonoscopy ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00930358

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Hotel Dieu Hospital
Paris, France, 75004
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
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Principal Investigator: Dominique Lamarque, MD, PhD Assistance Publique - Hôpitaux de Paris

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Responsible Party: Cécile Kedzia, Department Clinical Research of Developpement Identifier: NCT00930358    
Other Study ID Numbers: P060240
First Posted: June 30, 2009    Key Record Dates
Last Update Posted: April 6, 2011
Last Verified: April 2011
Keywords provided by Assistance Publique - Hôpitaux de Paris:
General anesthesia
Additional relevant MeSH terms:
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Nitrous Oxide
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Inhalation
Anesthetics, General
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents