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

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:

MedlinePlus related topics: Colonoscopy

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

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
Genders Eligible for Study:	Both
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

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

Contacts

Contact: Laure PAIN, MD

+33(0)6 85 43 63 00

laurepain@aol.com

Locations

France
Service d'Anestésie et Réanimation - Hôpital Beaujon	Recruiting
Clichy, France, 92110
Contact: Jean MANTZ, MD 33(0)140875000 Jean.mantz@bjn.aphp.fr
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 paul.segura@ch-colmar.rss.fr
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 langphilippe@yahoo.fr
Principal Investigator: Philippe LANG, MD
Sub-Investigator: Thierry STEINER, MD
Centre Ambulatoire-Clinique Saint-Odile	Not yet recruiting
Strasbourg, France, 67100
Contact: Gilles BURGUN, MD 33(0)388342500 Gilles.burgun@wanadoo.fr
Principal Investigator: Gilles BURGUN, MD
Centre Ambulatoire des Diaconesses	Recruiting
Strasbourg, France, 67000
Contact: Jean-Claude LLEU, MD 33(0)388257111 jclleu@wanadoo.fr
Principal Investigator: Jean-Claude LLEU, MD
Sub-Investigator: Joelle LLEU, MD
Sub-Investigator: Laurent JOUFFROY, MD
Service d'Anesthésie et Réanimation - Hôpital de Hautepierre	Not yet recruiting
Strasbourg, France, 67200
Contact: Gilles MAHOUDEAU, MD 33(0)388127075 gilles.mahoudeau@chru-strasbourg.fr
Principal Investigator: Gilles MAHOUDEAU, MD
Sub-Investigator: Chloe CHAUVIN, MD
Sub-Investigator: Thierry POTTECHER, MD

Sponsors and Collaborators

University Hospital, Strasbourg, France

Investigators

Principal Investigator:

Laure PAIN, MD

Hôpitaux Universitaires de Strasbourg

More Information

No publications provided

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
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Strasbourg, France:

anesthesia propofol ambulatory rhythm

Additional relevant MeSH terms:

Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs

Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013

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