Safety Study of Colonoscopy Under Sedation (KALINAG)

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.

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

Study Overview

• Status: Terminated
• Conditions: Colonoscopy Procedure
• Intervention / Treatment: Drug: MEOPA; Drug: general anaesthesia

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: Interventional
• Enrollment (Actual): 220
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Paris, France, 75004
    • Hotel Dieu Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MEOPA; MEOPA : equimolar nitrous oxide/oxygen mixture	Drug: MEOPA; anaesthetic gaz inhalation; Other Names: anaesthetic gaz inhalation
Active Comparator: General anesthesia; Gold standard	Drug: general anaesthesia; Anaesthetic intravenous route; Other Names: Anaesthetic intravenous route

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients who have well tolerated the colonoscopy as assessed by visual analogic scale (>75/100)		Immediately after the colonoscopy
The mean grade of patient anxiety before endoscopy	The mean grade of patient anxiety before endoscopy	After the colonoscopy

Secondary Outcome Measures

Outcome Measure	Time Frame
The mean tolerability of the colonoscopy between the group with sedation by nitrous oxide/oxygen mixture and the group with anesthesia	after the colonoscopy
The mean pain intensity during the procedure on a visual analogic scale	after the colonoscopy
The mean patient satisfaction on a visual analogic scale.	after the colonoscopy
The percentage of patients who agree to repeat the procedure in similar circumstances.	after the colonoscopy
The grade of difficulty of the colonoscopy evaluated by the endoscopist	After the colonoscopy
The mean duration of the endoscopy	After the colonoscopy
The percentage of caecum intubation	After the colonoscopy
The percentage of ileal intubation	After the colonoscopy
The opinion of the endoscopist on the tolerance of the colonoscopy	After the colonoscopy
The time to hospital discharge	After the issue of the colonoscopy
The Aldrete's score at the hospital discharge	After the colonoscopy
The number of patient who have refused the inclusion	After the issue of the colonoscopy

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Dominique Lamarque, MD, PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General 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. doi: 10.1055/s-2007-1004055.

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: June 29, 2009
• First Submitted That Met QC Criteria: June 29, 2009
• First Posted (Estimate): June 30, 2009

Study Record Updates

• Last Update Posted (Estimate): April 6, 2011
• Last Update Submitted That Met QC Criteria: April 5, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: Colonoscopy; Sedation; General anesthesia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: P060240