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TerminatedNCT00930358KALINAGUpdated Apr 6, 2011

Safety Study of Colonoscopy Under Sedation

A Phase 4 interventional study of MEOPA and general anaesthesia in Colonoscopy Procedure, sponsored by Assistance Publique - Hôpitaux de Paris. Terminated at 1 site in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2011-04-06.

Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 4, Interventional, and Treatment

Why this study was terminated
This study was stopped due to low inclusion
Phase
Phase 4
Study type
Interventional
Enrollment
220
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Colonoscopy Procedure

Keywords

  • Sedation
  • Colonoscopy
  • General anesthesia
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In context

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
  1. 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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
220 participants (actual)

Study arms

  • Experimental
    MEOPA

    MEOPA : equimolar nitrous oxide/oxygen mixture

    Drug: MEOPA

  • Active comparator
    General anesthesia

    Gold standard

    Drug: general anaesthesia

Interventions

  • DrugMEOPA

    anaesthetic gaz inhalation

    Also known as: anaesthetic gaz inhalation

  • Druggeneral anaesthesia

    Anaesthetic intravenous route

    Also known as: Anaesthetic intravenous route

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What researchers measure

Primary outcomes

  1. Percentage of patients who have well tolerated the colonoscopy as assessed by visual analogic scale (>75/100)

    Time frame: Immediately after the colonoscopy

  2. The mean grade of patient anxiety before endoscopy

    The mean grade of patient anxiety before endoscopy

    Time frame: After the colonoscopy

Secondary outcomes

  1. The mean tolerability of the colonoscopy between the group with sedation by nitrous oxide/oxygen mixture and the group with anesthesia

    Time frame: after the colonoscopy

  2. The mean pain intensity during the procedure on a visual analogic scale

    Time frame: after the colonoscopy

  3. The mean patient satisfaction on a visual analogic scale.

    Time frame: after the colonoscopy

  4. The percentage of patients who agree to repeat the procedure in similar circumstances.

    Time frame: after the colonoscopy

  5. The grade of difficulty of the colonoscopy evaluated by the endoscopist

    Time frame: After the colonoscopy

  6. The mean duration of the endoscopy

    Time frame: After the colonoscopy

  7. The percentage of caecum intubation

    Time frame: After the colonoscopy

  8. The percentage of ileal intubation

    Time frame: After the colonoscopy

  9. The opinion of the endoscopist on the tolerance of the colonoscopy

    Time frame: After the colonoscopy

  10. The time to hospital discharge

    Time frame: After the issue of the colonoscopy

  11. The Aldrete's score at the hospital discharge

    Time frame: After the colonoscopy

  12. The number of patient who have refused the inclusion

    Time frame: After the issue of the colonoscopy

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Study locations

1 site
  • Hotel Dieu Hospital
    Paris, 75004, France
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References and documents

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. PubMed 9083731 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00930358
Lead sponsor
Assistance Publique - Hôpitaux de Paris
First posted
Jun 30, 2009
Start date
Feb 2009
Primary completion
Jan 2011
Completion
Jan 2011
Last update
Apr 6, 2011

Study contacts

Dominique Lamarque, MD, PhD
principal investigator · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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