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Safety Study of Colonoscopy Under Sedation (KALINAG)

A

Assistance Publique - Hôpitaux de Paris

Status and phase

Terminated
Phase 4

Conditions

Colonoscopy Procedure

Treatments

Drug: MEOPA
Drug: general anaesthesia

Study type

Interventional

Funder types

Other

Identifiers

NCT00930358
P060240

Details and patient eligibility

About

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

Full 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.

Enrollment

220 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

  11. 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

220 participants in 2 patient groups

MEOPA
Experimental group
Description:
MEOPA : equimolar nitrous oxide/oxygen mixture
Treatment:
Drug: MEOPA
General anesthesia
Active Comparator group
Description:
Gold standard
Treatment:
Drug: general anaesthesia

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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