Clinical trial NCT00930358: Safety Study of Colonoscopy Under Sedation
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Colonoscopy Procedure
Keywords: Sedation
Colonoscopy
General anesthesia
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2009-06-30
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Percentage of patients who have well tolerated the colonoscopy as assessed by visual analogic scale (>75/100)
timeFrame: Immediately after the colonoscopy
measure: The mean grade of patient anxiety before endoscopy
timeFrame: After the colonoscopy
Secondary outcomes:
measure: The mean tolerability of the colonoscopy between the group with sedation by nitrous oxide/oxygen mixture and the group with anesthesia
timeFrame: after the colonoscopy
measure: The mean pain intensity during the procedure on a visual analogic scale
timeFrame: after the colonoscopy
measure: The mean patient satisfaction on a visual analogic scale.
timeFrame: after the colonoscopy
measure: The percentage of patients who agree to repeat the procedure in similar circumstances.
timeFrame: after the colonoscopy
measure: The grade of difficulty of the colonoscopy evaluated by the endoscopist
timeFrame: After the colonoscopy
measure: The mean duration of the endoscopy
timeFrame: After the colonoscopy
measure: The percentage of caecum intubation
timeFrame: After the colonoscopy
measure: The percentage of ileal intubation
timeFrame: After the colonoscopy
measure: The opinion of the endoscopist on the tolerance of the colonoscopy
timeFrame: After the colonoscopy
measure: The time to hospital discharge
timeFrame: After the issue of the colonoscopy
measure: The Aldrete's score at the hospital discharge
timeFrame: After the colonoscopy
measure: The number of patient who have refused the inclusion
timeFrame: After the issue of the colonoscopy
Other outcomes:
Locations:
city: Paris
country: France
facility: Hotel Dieu Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Dominique Lamarque, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.