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Safety Study of Colonoscopy Under Sedation (KALINAG)

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ClinicalTrials.gov Identifier: NCT00930358
Recruitment Status : Terminated (This study was stopped due to low inclusion)
First Posted : June 30, 2009
Last Update Posted : April 6, 2011
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE June 29, 2009
First Posted Date  ICMJE June 30, 2009
Last Update Posted Date April 6, 2011
Study Start Date  ICMJE February 2009
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2011)
  • Percentage of patients who have well tolerated the colonoscopy as assessed by visual analogic scale (>75/100) [ Time Frame: Immediately after the colonoscopy ]
  • The mean grade of patient anxiety before endoscopy [ Time Frame: After the colonoscopy ]
    The mean grade of patient anxiety before endoscopy
Original Primary Outcome Measures  ICMJE
 (submitted: June 29, 2009)
  • Percentage of patients who have well tolerated the colonoscopy as assessed by visual analogic scale (>75/100) [ Time Frame: Immediately after the colonoscopy ]
  • The mean grade of patient anxiety before endoscopy [ Time Frame: After the colonoscopy ]
Change History Complete list of historical versions of study NCT00930358 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2009)
  • 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 ]
  • The mean pain intensity during the procedure on a visual analogic scale [ Time Frame: after the colonoscopy ]
  • The mean patient satisfaction on a visual analogic scale. [ Time Frame: after the colonoscopy ]
  • The percentage of patients who agree to repeat the procedure in similar circumstances. [ Time Frame: after the colonoscopy ]
  • The grade of difficulty of the colonoscopy evaluated by the endoscopist [ Time Frame: After the colonoscopy ]
  • The mean duration of the endoscopy [ Time Frame: After the colonoscopy ]
  • The percentage of caecum intubation [ Time Frame: After the colonoscopy ]
  • The percentage of ileal intubation [ Time Frame: After the colonoscopy ]
  • The opinion of the endoscopist on the tolerance of the colonoscopy [ Time Frame: After the colonoscopy ]
  • The time to hospital discharge [ Time Frame: After the issue of the colonoscopy ]
  • The Aldrete's score at the hospital discharge [ Time Frame: After the colonoscopy ]
  • The number of patient who have refused the inclusion [ Time Frame: After the issue of the colonoscopy ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of Colonoscopy Under Sedation
Official Title  ICMJE 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.
Brief Summary The aim of this study was to compare the analgesia provided by nitrous oxide/oxygen sedation or general anesthesia for colonoscopy
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colonoscopy Procedure
Intervention  ICMJE
  • Drug: MEOPA
    anaesthetic gaz inhalation
    Other Name: anaesthetic gaz inhalation
  • Drug: general anaesthesia
    Anaesthetic intravenous route
    Other Name: Anaesthetic intravenous route
Study Arms  ICMJE
  • Experimental: MEOPA
    MEOPA : equimolar nitrous oxide/oxygen mixture
    Intervention: Drug: MEOPA
  • Active Comparator: General anesthesia
    Gold standard
    Intervention: Drug: general anaesthesia
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 29, 2009)
220
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2011
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00930358
Other Study ID Numbers  ICMJE P060240
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cécile Kedzia, Department Clinical Research of Developpement
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dominique Lamarque, MD, PhD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP