NCT00930358

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2009

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 30, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

April 6, 2011

Status Verified

April 1, 2011

Enrollment Period

1.9 years

First QC Date

June 29, 2009

Last Update Submit

April 5, 2011

Conditions

Colonoscopy Procedure

Keywords

SedationColonoscopyGeneral anesthesia

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (12)

  • 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

  • +7 more secondary outcomes

Study Arms (2)

MEOPA

EXPERIMENTAL

MEOPA : equimolar nitrous oxide/oxygen mixture

Drug: MEOPA

General anesthesia

ACTIVE COMPARATOR

Gold standard

Drug: general anaesthesia

Interventions

MEOPADRUG

anaesthetic gaz inhalation

Also known as: anaesthetic gaz inhalation
MEOPA
general anaesthesiaDRUG

Anaesthetic intravenous route

Also known as: Anaesthetic intravenous route
General anesthesia

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient referred for colonoscopy with general anesthesia
  • Age above 18 et below 75 year
  • Patient who gave an informed consent

You may not qualify if:

  • Age below 18 ou above 75
  • Need for gastroscopy in the same procedure than colonoscopy
  • History of surgery wih resection more extended than half of the colon
  • Dementia with autonomy loss or psychiatric disorder non controlled by therapeutic
  • Severe congestive heart failure or evolutive heart ischemia
  • Recent cerebral stroke
  • Hemodynamic instability
  • Respiratory failure, severe chronic obstructive pulmonary (including asthma) or progressive pneumothorax
  • Hepatic failure (Child-Pugh score\> 9)
  • Terminal renal failure 11 Hematopoietic disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hotel Dieu Hospital

Paris, 75004, France

Location

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

    PMID: 9083731BACKGROUND

MeSH Terms

Interventions

MeopaAnesthesia, General

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Study Officials

  • Dominique Lamarque, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 29, 2009

First Posted

June 30, 2009

Study Start

February 1, 2009

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

April 6, 2011

Record last verified: 2011-04

Locations

FR(1)