Anesthesia, GeneralPosoAnesNCT00896714
Factors Influencing Anesthetic Drug Requirement
A study testing Closed loop anesthesia in people with Anesthesia, General, run by Hopital Foch at 4 sites in France.
Trial summary
The main objective of the study is to analyze the influence of several environmental (i.e., timing: seasonal, circadian) and demographic conditions (i.e., age, gender, menstrual cycle) on anesthetic drug requirements (hypnotic and opiate). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, General
- What is being tested?
- Closed loop anesthesia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,278 participants
- Where
- 4 sitesFrance
- Study dates
- 4 May 2009to 31 Jul 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing scheduled surgery under general anesthesia, agreeing to participate in the study
Who cannot join
- Age under 18 years
- Pregnancy, breastfeeding woman
- Allergy to propofol, soybeans or peanuts
- Allergy to sufentanil, remifentanil, morphine,
- Allergy to a muscle relaxant or to any of its excipients
- Known hypersensitivity to sufentanil, remifentanil, or to other derivates of fentanyl
Show all 11Show fewer
- History of central neurological disorder or brain injury
- Patient with dementia
- Patient with pacemaker
- Patient receiving psychotropic drugs or morphine agonist-antagonists
- Surgery on the skull and/or operating position preventing the use of a bispectral index sensor in suitable conditions
Trial locations and contacts
4 sites in 1 country.
France4 sites
CHU Besançon
Besançon, 25000
Centre Hospitalier de Dreux
Dreux, 28102
Hôpital Tenon
Paris, 75020
Hôpital Foch
Suresnes, 92151
About this study
Official title: Impact of Environmental and Demographic Factors on Pre-operative Doses of Anesthetic Agents (Prospective Multicenter Study)
The main objective of the study is to analyze the influence of several environmental (i.e., timing: seasonal, circadian) and demographic conditions (i.e., age, gender, menstrual cycle) on anesthetic drug requirements (hypnotic and opiate).
- Conditions
- Anesthesia, General
- Being tested
- Closed loop anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed loop anesthesiaDevice
Propofol and Remifentanil are administered automatically using a closed-loop system
| Study group | Role | What they receive |
|---|---|---|
| Closed loop anesthesia | Experimental | Not described Receives: Device: Closed loop anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
The dose of propofol required to maintain BIS (bispectral index) between 40 and 60 during maintenance of anesthesia
Measured: during anesthesia
Secondary outcomes (9)
Propofol dose required for anesthesia induction
Measured: intraoperative period
Remifentanil dose required for anesthesia induction
Measured: intraoperative period
Remifentanil dose requirements for maintenance of anesthesia
Measured: intraoperative period
Wake up time
Measured: intraoperative period
Explicit memorisation
Measured: post-operative period
Propofol and remifentanil requirements according to the surgical technique
Measured: post-operative period
Analysis of subgroup of patients according to their clinical status
analysis of subgroup of patients according to their clinical status (eg: age)
Measured: post-operative period
Analysis of subgroup of patients according to the surgical approach
analysis of subgroup of patients according to the surgical approach ("open" surgery versus "minimal invasive" surgery)
Measured: post-operative period
Analysis of subgroup of patients according to their pathology
analysis of subgroup of patients according to their pathology (eg: burns)
Measured: post-operative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study start4 May 2009
- Primary completion31 Jul 2017
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, GeneralStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,278 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Fischler, MD, Study chair, Hôpital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00896714
- Sponsor's protocol ID
- 2008/44
- Acronym
- PosoAnes
- Status last verified
- Aug 2019
- First submitted
- 8 May 2009
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Environmental and Demographic Factors on Pre-operative Doses of Anesthetic Agents (Prospective Multicenter Study)
- ClinicalTrials.gov ID
- NCT00896714
- Acronym / sponsor ID
- PosoAnes / 2008/44
- Conditions
- Anesthesia, General
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,278 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 4 May 2009 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 12 May 2009 (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.
The main objective of the study is to analyze the influence of several environmental (i.e., timing: seasonal, circadian) and demographic conditions (i.e., age, gender, menstrual cycle) on anesthetic drug requirements (hypnotic and opiate).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Closed loop anesthesia | Experimental | Device: Closed loop anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing scheduled surgery under general anesthesia, agreeing to participate in the study
Key exclusion criteria (11 listed)
- Age under 18 years
- Pregnancy, breastfeeding woman
- Allergy to propofol, soybeans or peanuts
- Allergy to sufentanil, remifentanil, morphine,
- Allergy to a muscle relaxant or to any of its excipients
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 |
|---|---|---|
| Closed loop anesthesiaPropofol and Remifentanil are administered automatically using a closed-loop system | Device | Closed loop anesthesia |
Primary outcome
The dose of propofol required to maintain BIS (bispectral index) between 40 and 60 during maintenance of anesthesia
Time frame: during anesthesia
9 secondary outcomes
Propofol dose required for anesthesia induction
Time frame: intraoperative period
Remifentanil dose required for anesthesia induction
Time frame: intraoperative period
Remifentanil dose requirements for maintenance of anesthesia
Time frame: intraoperative period
Wake up time
Time frame: intraoperative period
Explicit memorisation
Time frame: post-operative period
Propofol and remifentanil requirements according to the surgical technique
Time frame: post-operative period
Analysis of subgroup of patients according to their clinical status
Time frame: post-operative period
Analysis of subgroup of patients according to the surgical approach
Time frame: post-operative period
Analysis of subgroup of patients according to their pathology
Time frame: post-operative period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
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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.
Marc Fischler, MD study chair
Hôpital Foch
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closed loop anesthesia in people with Anesthesia, General, run by Hopital Foch at 4 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 1 inclusion and 11 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: finished, as of the sponsor's last update on 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The dose of propofol required to maintain BIS (bispectral index) between 40 and 60 during maintenance of anesthesia (time frame: during 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 14 Aug 2019.