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Ambulatory Anesthesia and Light Therapy (LI-AMB)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by University Hospital, Strasbourg, France.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT00813345
First received: December 22, 2008
Last updated: April 24, 2009
Last verified: April 2009
History of Changes

December 22, 2008
April 24, 2009
January 2009
December 2009   (final data collection date for primary outcome measure)
Modification of on parametric analysis of circadian rhythm of rest-activity post anesthesia as compared to reference period (within factor) ; between factor : light intensity group [ Time Frame: Within the first 5 days after anesthesia ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00813345 on ClinicalTrials.gov Archive Site
Influence of gene period 3 phenotype on the effect of anesthesia [ Time Frame: Blood sample taken the day of the anesthesia ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Ambulatory Anesthesia and Light Therapy
A Role for Light Therapy at Immediate Recovery From Short Duration Ambulatory Anesthesia to Prevent Dysregulation of Circadian Rest-Activity Rhythm in Patients Submitted to Colonoscopy.

We previously evidenced in both animal models and patients that a short duration ambulatory anesthesia impacts the circadian rest-activity biological rhythm, at least during the first 3 days. The light is the main, natural synchronisateur, of the biological cerebral clock, and is used as therapeutics in chronic disturbances of the circadian rest activity rhythm and of the sleep (Alzheimer disease for example). We would like to test for a simple and safe strategy to prevent such a long-lasting effect of anesthesia on biological clock:the increase of the light intensity at a still physiological level during the initial phase of recovery from anesthesia by using a particular artificial light of color spectrum similar to natural sun daylight.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
  • Anesthesia
  • Colonoscopy
  • Other: light therapy (1500 lux)
    light therapy (1500 lux) for 90 minutes
  • Other: standard light (100 LUX)
    standard light (100 LUX) for 90 minutes
  • Experimental: A - Light therapy
    Light therapy (1500 lux)
    Intervention: Other: light therapy (1500 lux)
  • Placebo Comparator: B - identical control lamp
    identical control lamp
    Intervention: Other: standard light (100 LUX)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
360
June 2010
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • ASA I & II
  • ambulatory anesthesia for colonoscopy on Monday or Tuesday
  • social security

Exclusion Criteria:

  • treatment for cancer
  • hypnotics, beta-bloquers
  • pregnancy
  • legal supervision
  • trans 5 meridian travel in the last two months
Both
30 Years to 70 Years
No
Contact: Laure PAIN, MD +33(0)6 85 43 63 00 laurepain@aol.com
France
 
NCT00813345
4057, 2007-A00867-46
No
Christine GEILLER, Direction de la Recherche Clinique et de l'Innovation - Hôpitaux Universitaires de Strasbourg
University Hospital, Strasbourg, France
Not Provided
Principal Investigator: Laure PAIN, MD Hôpitaux Universitaires de Strasbourg
University Hospital, Strasbourg, France
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP