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.

Sponsors

Lead Sponsor: University Hospital, Strasbourg, France

Source 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.

Overall Status Unknown status
Start Date January 2009
Completion Date June 2010
Primary Completion Date December 2009
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
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 Within the first 5 days after anesthesia
Secondary Outcome
Measure Time Frame
Influence of gene period 3 phenotype on the effect of anesthesia Blood sample taken the day of the anesthesia
Enrollment 360
Condition
Intervention

Intervention Type: Other

Intervention Name: light therapy (1500 lux)

Description: light therapy (1500 lux) for 90 minutes

Arm Group Label: A - Light therapy

Intervention Type: Other

Intervention Name: standard light (100 LUX)

Description: standard light (100 LUX) for 90 minutes

Arm Group Label: B - identical control lamp

Eligibility

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

Gender: All

Minimum Age: 30 Years

Maximum Age: 70 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Laure PAIN, MD Principal Investigator Hôpitaux Universitaires de Strasbourg
Overall Contact

Last Name: Laure PAIN, MD

Phone: +33(0)6 85 43 63 00

Email: [email protected]

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

France

Verification Date

April 2009

Responsible Party

Name Title: Christine GEILLER

Organization: Direction de la Recherche Clinique et de l'Innovation - Hôpitaux Universitaires de Strasbourg

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Label: A - Light therapy

Type: Experimental

Description: Light therapy (1500 lux)

Label: B - identical control lamp

Type: Placebo Comparator

Description: identical control lamp

Acronym LI-AMB
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Single (Participant)

Source: ClinicalTrials.gov