Ambulatory Anesthesia and Light Therapy (LI-AMB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00813345
Recruitment Status : Unknown
Verified April 2009 by University Hospital, Strasbourg, France.
Recruitment status was:  Recruiting
First Posted : December 23, 2008
Last Update Posted : April 27, 2009
Information provided by:
University Hospital, Strasbourg, France

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Anesthesia Colonoscopy Other: light therapy (1500 lux) Other: standard light (100 LUX) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: 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.
Study Start Date : January 2009
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: A - Light therapy
Light therapy (1500 lux)
Other: light therapy (1500 lux)
light therapy (1500 lux) for 90 minutes
Placebo Comparator: B - identical control lamp
identical control lamp
Other: standard light (100 LUX)
standard light (100 LUX) for 90 minutes

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Influence of gene period 3 phenotype on the effect of anesthesia [ Time Frame: Blood sample taken the day of the anesthesia ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00813345

Contact: Laure PAIN, MD +33(0)6 85 43 63 00

Service d'Anestésie et Réanimation - Hôpital Beaujon Recruiting
Clichy, France, 92110
Contact: Jean MANTZ, MD    33(0)140875000   
Principal Investigator: Jean MANTZ, MD         
Sub-Investigator: Agnès BONNET-BOURICHON, MD         
Service d'Anesthésie et Réanimation - Hôpital Pasteur Recruiting
Colmar, France, 68024
Contact: Paul SEGURA, MD    33(0)389124161   
Principal Investigator: Paul SEGURA, MD         
Sub-Investigator: Mohamed Khalil AIT EL HADDAD, MD         
Service d'Anesthésie et Réanimation, Hôpital d'Instruction des Armées Legouest Recruiting
Metz, France, 57998
Contact: Philippe LANG, MD    33(0)387564760   
Principal Investigator: Philippe LANG, MD         
Sub-Investigator: Thierry STEINER, MD         
Centre Ambulatoire des Diaconesses Recruiting
Strasbourg, France, 67000
Contact: Jean-Claude LLEU, MD    33(0)388257111   
Principal Investigator: Jean-Claude LLEU, MD         
Sub-Investigator: Joelle LLEU, MD         
Sub-Investigator: Laurent JOUFFROY, MD         
Centre Ambulatoire-Clinique Saint-Odile Not yet recruiting
Strasbourg, France, 67100
Contact: Gilles BURGUN, MD    33(0)388342500   
Principal Investigator: Gilles BURGUN, MD         
Service d'Anesthésie et Réanimation - Hôpital de Hautepierre Not yet recruiting
Strasbourg, France, 67200
Contact: Gilles MAHOUDEAU, MD    33(0)388127075   
Principal Investigator: Gilles MAHOUDEAU, MD         
Sub-Investigator: Chloe CHAUVIN, MD         
Sub-Investigator: Thierry POTTECHER, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Principal Investigator: Laure PAIN, MD Hôpitaux Universitaires de Strasbourg

Responsible Party: Christine GEILLER, Direction de la Recherche Clinique et de l'Innovation - Hôpitaux Universitaires de Strasbourg Identifier: NCT00813345     History of Changes
Other Study ID Numbers: 4057
First Posted: December 23, 2008    Key Record Dates
Last Update Posted: April 27, 2009
Last Verified: April 2009

Keywords provided by University Hospital, Strasbourg, France:
anesthesia propofol ambulatory rhythm

Additional relevant MeSH terms:
Central Nervous System Depressants
Physiological Effects of Drugs