Ambulatory Anesthesia and Light Therapy

Anesthesia Clinical Trial

— LI-AMB  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00813345
• Other study ID #: 4057
• Secondary ID: 2007-A00867-46
• Status: Recruiting
• Phase: N/A
• First received: December 22, 2008
• Last updated: April 24, 2009
• Start date: January 2009
• Est. completion date: June 2010

Study information

• Verified date: April 2009
• Source: University Hospital, Strasbourg, France
• Contact: Laure PAIN, MD
• Phone: +33(0)6 85 43 63 00
• Email: laurepain[@]aol.com
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: June 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anesthesia
• Colonoscopy

Intervention

Other:
• light therapy (1500 lux)
light therapy (1500 lux) for 90 minutes
• standard light (100 LUX)
standard light (100 LUX) for 90 minutes

Locations

Country	Name	City	State
France	Service d'Anestésie et Réanimation - Hôpital Beaujon	Clichy
France	Service d'Anesthésie et Réanimation - Hôpital Pasteur	Colmar
France	Service d'Anesthésie et Réanimation, Hôpital d'Instruction des Armées Legouest	Metz
France	Centre Ambulatoire des Diaconesses	Strasbourg
France	Centre Ambulatoire-Clinique Saint-Odile	Strasbourg
France	Service d'Anesthésie et Réanimation - Hôpital de Hautepierre	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Influence of gene period 3 phenotype on the effect of anesthesia		Blood sample taken the day of the anesthesia	No