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Ambulatory Anesthesia and Light Therapy (LI-AMB)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
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
  Purpose
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 Intervention
Anesthesia
Colonoscopy
Other: light therapy (1500 lux)
Other: standard light (100 LUX)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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.

Resource links provided by NLM:


Further study details as provided by University Hospital, Strasbourg, France:

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

Estimated Enrollment: 360
Study Start Date: January 2009
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00813345

Locations
France
Service d'Anestésie et Réanimation - Hôpital Beaujon
Clichy, France, 92110
Service d'Anesthésie et Réanimation - Hôpital Pasteur
Colmar, France, 68024
Service d'Anesthésie et Réanimation, Hôpital d'Instruction des Armées Legouest
Metz, France, 57998
Centre Ambulatoire des Diaconesses
Strasbourg, France, 67000
Centre Ambulatoire-Clinique Saint-Odile
Strasbourg, France, 67100
Service d'Anesthésie et Réanimation - Hôpital de Hautepierre
Strasbourg, France, 67200
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: Laure PAIN, MD Hôpitaux Universitaires de Strasbourg
  More Information

Responsible Party: Christine GEILLER, Direction de la Recherche Clinique et de l'Innovation - Hôpitaux Universitaires de Strasbourg
ClinicalTrials.gov Identifier: NCT00813345     History of Changes
Other Study ID Numbers: 4057  2007-A00867-46 
Study First Received: December 22, 2008
Last Updated: April 24, 2009

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

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

ClinicalTrials.gov processed this record on February 20, 2017