Ambulatory Anesthesia and Light Therapy (LI-AMB)

April 24, 2009 updated by: University Hospital, Strasbourg, France

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

360

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Clichy, France, 92110
        • Recruiting
        • Service d'Anestésie et Réanimation - Hôpital Beaujon
        • Contact:
        • Principal Investigator:
          • Jean MANTZ, MD
        • Sub-Investigator:
          • Agnès BONNET-BOURICHON, MD
      • Colmar, France, 68024
        • Recruiting
        • Service d'Anesthésie et Réanimation - Hôpital Pasteur
        • Contact:
        • Principal Investigator:
          • Paul SEGURA, MD
        • Sub-Investigator:
          • Mohamed Khalil AIT EL HADDAD, MD
      • Metz, France, 57998
        • Recruiting
        • Service d'Anesthésie et Réanimation, Hôpital d'Instruction des Armées Legouest
        • Contact:
        • Principal Investigator:
          • Philippe LANG, MD
        • Sub-Investigator:
          • Thierry STEINER, MD
      • Strasbourg, France, 67000
        • Recruiting
        • Centre Ambulatoire des Diaconesses
        • Contact:
        • Principal Investigator:
          • Jean-Claude LLEU, MD
        • Sub-Investigator:
          • Joelle LLEU, MD
        • Sub-Investigator:
          • Laurent JOUFFROY, MD
      • Strasbourg, France, 67100
        • Not yet recruiting
        • Centre Ambulatoire-Clinique Saint-Odile
        • Contact:
        • Principal Investigator:
          • Gilles BURGUN, MD
      • Strasbourg, France, 67200
        • Not yet recruiting
        • Service d'Anesthésie et Réanimation - Hôpital de Hautepierre
        • Contact:
        • Principal Investigator:
          • Gilles MAHOUDEAU, MD
        • Sub-Investigator:
          • Chloe CHAUVIN, MD
        • Sub-Investigator:
          • Thierry POTTECHER, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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
Time Frame: Within the first 5 days after anesthesia
Within the first 5 days after anesthesia

Secondary Outcome Measures

Outcome Measure
Time Frame
Influence of gene period 3 phenotype on the effect of anesthesia
Time Frame: Blood sample taken the day of the anesthesia
Blood sample taken the day of the anesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Principal Investigator: Laure PAIN, MD, Hopitaux Universitaires de Strasbourg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Anticipated)

December 1, 2009

Study Completion (Anticipated)

June 1, 2010

Study Registration Dates

First Submitted

December 22, 2008

First Submitted That Met QC Criteria

December 22, 2008

First Posted (Estimate)

December 23, 2008

Study Record Updates

Last Update Posted (Estimate)

April 27, 2009

Last Update Submitted That Met QC Criteria

April 24, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 4057
  • 2007-A00867-46

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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