Safety Study of Colonoscopy Under Sedation

Colonoscopy Procedure Clinical Trial

— KALINAG  

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00930358
• Other study ID #: P060240
• Status: Terminated
• Phase: Phase 4
• First received: June 29, 2009
• Last updated: April 5, 2011
• Start date: February 2009
• Est. completion date: January 2011

Study information

• Verified date: April 2011
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 220
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colonoscopy Procedure

Intervention

Drug:
• MEOPA
anaesthetic gaz inhalation
• general anaesthesia
Anaesthetic intravenous route

Locations

Country	Name	City	State
France	Hotel Dieu Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients who have well tolerated the colonoscopy as assessed by visual analogic scale (>75/100)		Immediately after the colonoscopy	Yes
Primary	The mean grade of patient anxiety before endoscopy	The mean grade of patient anxiety before endoscopy	After the colonoscopy	Yes
Secondary	The mean tolerability of the colonoscopy between the group with sedation by nitrous oxide/oxygen mixture and the group with anesthesia		after the colonoscopy	Yes
Secondary	The mean pain intensity during the procedure on a visual analogic scale		after the colonoscopy	Yes
Secondary	The mean patient satisfaction on a visual analogic scale.		after the colonoscopy	Yes
Secondary	The percentage of patients who agree to repeat the procedure in similar circumstances.		after the colonoscopy	Yes
Secondary	The grade of difficulty of the colonoscopy evaluated by the endoscopist		After the colonoscopy	Yes
Secondary	The mean duration of the endoscopy		After the colonoscopy	Yes
Secondary	The percentage of caecum intubation		After the colonoscopy	Yes
Secondary	The percentage of ileal intubation		After the colonoscopy	Yes
Secondary	The opinion of the endoscopist on the tolerance of the colonoscopy		After the colonoscopy	Yes
Secondary	The time to hospital discharge		After the issue of the colonoscopy	Yes
Secondary	The Aldrete's score at the hospital discharge		After the colonoscopy	Yes
Secondary	The number of patient who have refused the inclusion		After the issue of the colonoscopy	No