AnesthesiaLI-AMBNCT00813345
Ambulatory Anesthesia and Light Therapy
A study testing light therapy (1500 lux) and standard light (100 LUX) in people with Anesthesia and Colonoscopy, run by University Hospital, Strasbourg, France at 6 sites in France.
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. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Anesthesia, Colonoscopy
- What is being tested?
- light therapy (1500 lux) and standard light (100 LUX)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 6 sitesFrance
- Study dates
- Jan 2009to Jun 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I \& II
- ambulatory anesthesia for colonoscopy on Monday or Tuesday
- social security
Who cannot join
- treatment for cancer
- hypnotics, beta-bloquers
- pregnancy
- legal supervision
- trans 5 meridian travel in the last two months
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites, 6 recruiting
- Recruiting
Service d'Anestésie et Réanimation - Hôpital Beaujon
Clichy, 92110
Jean MANTZ, MD, 33(0)140875000, Jean.mantz@bjn.aphp.fr
Jean MANTZ, MD
- Recruiting
Service d'Anesthésie et Réanimation - Hôpital Pasteur
Colmar, 68024
Paul SEGURA, MD, 33(0)389124161, paul.segura@ch-colmar.rss.fr
Paul SEGURA, MD
- Recruiting
Service d'Anesthésie et Réanimation, Hôpital d'Instruction des Armées Legouest
Metz, 57998
Philippe LANG, MD, 33(0)387564760, langphilippe@yahoo.fr
Philippe LANG, MD
- Recruiting
Centre Ambulatoire des Diaconesses
Strasbourg, 67000
Jean-Claude LLEU, MD, 33(0)388257111, jclleu@wanadoo.fr
Jean-Claude LLEU, MD
- Not yet recruiting
Centre Ambulatoire-Clinique Saint-Odile
Strasbourg, 67100
Gilles BURGUN, MD, 33(0)388342500, Gilles.burgun@wanadoo.fr
Gilles BURGUN, MD
- Not yet recruiting
Service d'Anesthésie et Réanimation - Hôpital de Hautepierre
Strasbourg, 67200
Gilles MAHOUDEAU, MD, 33(0)388127075, gilles.mahoudeau@chru-strasbourg.fr
Gilles MAHOUDEAU, MD
About this study
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.
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.
- Conditions
- Anesthesia, Colonoscopy
- Being tested
- light therapy (1500 lux), standard light (100 LUX)
- Keywords
- anesthesia propofol ambulatory rhythm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
light therapy (1500 lux)Other
light therapy (1500 lux) for 90 minutes
standard light (100 LUX)Other
standard light (100 LUX) for 90 minutes
| Study group | Role | What they receive |
|---|---|---|
| A - Light therapy | Experimental | Light therapy (1500 lux) Receives: Other: light therapy (1500 lux) |
| B - identical control lamp | Placebo comparator | identical control lamp Receives: Other: standard light (100 LUX) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within the first 5 days after anesthesia
Secondary outcomes (1)
Influence of gene period 3 phenotype on the effect of anesthesia
Measured: Blood sample taken the day of the anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2008 (estimated)
- Study startJan 2009
- Primary completionDec 2009 (estimated)
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Investigators
- Laure PAIN, MD, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00813345
- Sponsor's protocol ID
- 4057
- Other IDs
- 2007-A00867-46
- Acronym
- LI-AMB
- Status last verified
- Apr 2009
- First submitted
- 22 Dec 2008
- Last updated
- 27 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00813345
- Acronym / sponsor ID
- LI-AMB / 4057
- Conditions
- Anesthesia, Colonoscopy
- Keywords
- anesthesia propofol ambulatory rhythm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 23 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A - Light therapy | Experimental | Other: light therapy (1500 lux)Light therapy (1500 lux) |
| B - identical control lamp | Placebo comparator | Other: standard light (100 LUX)identical control lamp |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA I \& II
- ambulatory anesthesia for colonoscopy on Monday or Tuesday
- social security
Key exclusion criteria (5 listed)
- treatment for cancer
- hypnotics, beta-bloquers
- pregnancy
- legal supervision
- trans 5 meridian travel in the last two months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| light therapy (1500 lux)light therapy (1500 lux) for 90 minutes | Other | A - Light therapy |
| standard light (100 LUX)standard light (100 LUX) for 90 minutes | Other | B - identical control lamp |
Primary outcome
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
1 secondary outcome
Influence of gene period 3 phenotype on the effect of anesthesia
Time frame: Blood sample taken the day of the anesthesia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laure PAIN, MD principal investigator
Hôpitaux Universitaires de Strasbourg
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing light therapy (1500 lux) and standard light (100 LUX) in people with Anesthesia and Colonoscopy, run by University Hospital, Strasbourg, France at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laure PAIN, MD (+33(0)6 85 43 63 00, laurepain@aol.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2009.