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Ambulatory Anesthesia and Light Therapy (LI-AMB)

U

University Hospital, Strasbourg, France

Status

Unknown

Conditions

Colonoscopy
Anesthesia

Treatments

Other: light therapy (1500 lux)
Other: standard light (100 LUX)

Study type

Interventional

Funder types

Other

Identifiers

NCT00813345
2007-A00867-46
4057

Details and patient eligibility

About

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.

Enrollment

360 estimated patients

Sex

All

Ages

30 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

360 participants in 2 patient groups, including a placebo group

A - Light therapy
Experimental group
Description:
Light therapy (1500 lux)
Treatment:
Other: light therapy (1500 lux)
B - identical control lamp
Placebo Comparator group
Description:
identical control lamp
Treatment:
Other: standard light (100 LUX)

Trial contacts and locations

6

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Central trial contact

Laure PAIN, MD

Data sourced from clinicaltrials.gov

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