Ambulatory Anesthesia and Light Therapy | NCT00813345

Studies
Ambulatory Anesthesia and Light Therapy

NCT00813345

Sponsor

University Hospital, Strasbourg, France

Status

Unknown status

Last Update Posted

Apr 27, 2009Estimated

Enrollment

360Estimated

Phase

Not Applicable

Conditions

Anesthesia
Colonoscopy

Interventions

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

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2007-A00867-46

Status Module

Record Verification Date

Apr 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Dec 2009Estimated

Completion Date

Jun 2010Estimated

First Submitted Date

Dec 22, 2008

First Submission Date that Met QC Criteria

Dec 22, 2008

First Posted Date

Dec 23, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 24, 2009

Last Update Posted Date

Apr 27, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

360Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A - Light therapy	Experimental	Light therapy (1500 lux)	Other: light therapy (1500 lux)
B - identical control lamp	Placebo Comparator	identical control lamp	Other: standard light (100 LUX)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
light therapy (1500 lux)	Other	light therapy (1500 lux) for 90 minutes	A - Light therapy

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Laure PAIN, MD	Contact	+33(0)6 85 43 63 00		laurepain@aol.com

Overall Officials

Name	Affiliation	Role
Laure PAIN, MD	Hôpitaux Universitaires de Strasbourg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service d'Anestésie et Réanimation - Hôpital Beaujon	Recruiting	Clichy		92110	France