Safety Study of Colonoscopy Under Sedation (KALINAG)

This study has been terminated.
(This study was stopped due to low inclusion)
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00930358
First received: June 29, 2009
Last updated: April 5, 2011
Last verified: April 2011
  Purpose

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


Condition Intervention Phase
Colonoscopy Procedure
Drug: MEOPA
Drug: general anaesthesia
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

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


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • The mean pain intensity during the procedure on a visual analogic scale [ Time Frame: after the colonoscopy ] [ Designated as safety issue: Yes ]
  • The mean patient satisfaction on a visual analogic scale. [ Time Frame: after the colonoscopy ] [ Designated as safety issue: Yes ]
  • The percentage of patients who agree to repeat the procedure in similar circumstances. [ Time Frame: after the colonoscopy ] [ Designated as safety issue: Yes ]
  • The grade of difficulty of the colonoscopy evaluated by the endoscopist [ Time Frame: After the colonoscopy ] [ Designated as safety issue: Yes ]
  • The mean duration of the endoscopy [ Time Frame: After the colonoscopy ] [ Designated as safety issue: Yes ]
  • The percentage of caecum intubation [ Time Frame: After the colonoscopy ] [ Designated as safety issue: Yes ]
  • The percentage of ileal intubation [ Time Frame: After the colonoscopy ] [ Designated as safety issue: Yes ]
  • The opinion of the endoscopist on the tolerance of the colonoscopy [ Time Frame: After the colonoscopy ] [ Designated as safety issue: Yes ]
  • The time to hospital discharge [ Time Frame: After the issue of the colonoscopy ] [ Designated as safety issue: Yes ]
  • The Aldrete's score at the hospital discharge [ Time Frame: After the colonoscopy ] [ Designated as safety issue: Yes ]
  • The number of patient who have refused the inclusion [ Time Frame: After the issue of the colonoscopy ] [ Designated as safety issue: No ]

Enrollment: 220
Study Start Date: February 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MEOPA
MEOPA : equimolar nitrous oxide/oxygen mixture
Drug: MEOPA
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00930358

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

Publications:
Responsible Party: Cécile Kedzia, Department Clinical Research of Developpement
ClinicalTrials.gov Identifier: NCT00930358     History of Changes
Other Study ID Numbers: P060240
Study First Received: June 29, 2009
Last Updated: April 5, 2011
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Sedation
Colonoscopy
General anesthesia

Additional relevant MeSH terms:
Anesthetics
Nitrous Oxide
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Inhalation
Anesthetics, General

ClinicalTrials.gov processed this record on April 17, 2014