General AnesthesiaELANCT01198639
One-year Mortality After Surgery and Low Bispectral Index
A study testing manual administration of iv anesthetics (propofol and remifentanil) using the Toolbox platform and closed-loop administration of iv anesthetics (propofol and remifentanil) using the Toolbox platform in people with General Anesthesia, run by Hopital Foch at 22 sites in France.
Trial summary
A correlation between deep anesthesia (defined as time with Bispectral Index (BIS) lower than 45) and death within 1 yr after surgery has previously been reported. In order to confirm or refute these findings, the investigators have designed a study which compares two methods of administration for total intravenous… Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- General Anesthesia
- What is being tested?
- manual administration of iv anesthetics (propofol and remifentanil) using the Toolbox platform and closed-loop administration of iv anesthetics (propofol and remifentanil) using the Toolbox platform
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,044 participants
- Where
- 22 sitesFrance
- Study dates
- 13 Sep 2010to 20 Feb 2015
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiology patient classification status I, II and III
- patients aged between 50 and 85 years old
- born in France
- surgical procedures lasting more than one hour
Who cannot join
- American Society of Anesthesiology patient classification status IV
- patients born out of France
- pace-maker
- surgical procedure on the skull or avoiding an adequate positioning of the bispectral index electrode dementia, history of central nervous system disease (tumor, vascular event, Parkinson disease, ...)
- psychiatric illness (severe depression or psychosis), patients receiving a psychotropic treatment
- anesthesia performed during the year before inclusion in this study except for diagnostic procedures
- allergy to propofol, soja, peanuts, or to sufentanil, remifentanil, or morphine, to a myorelaxant or to an excipient,
- hypersensibility to sufentanil, to remifentanil, or to other derivate of fentanyl
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
France22 sites
CHU Victor Dupuy
Argenteuil, 95107
CHU Besançon
Besançon, 25030
Hôpitaux Universitaires Paris-Seine St Denis CHU Avicenne
Bobigny, 93000
Clinique Saint Augustin
Bordeaux
Clinique Saint Vincent de Paul
Bourgoin
Hôpital Femme-Mère-Enfant
Bron
CH de Chartres Louis Pasteur
Chartres
H.I.A Percy
Clamart
Centre Jean Perrin
Clermont-Ferrand
Clinique des Deux Caps
Coquelles, 62231
Clinique Fontaine-lès-Dijon
Dijon, 21121
CHU de Grenoble
Grenoble, 38700
Institut Hospitalier Franco Britannique
Levallois-Perret
Institut Paoli-Calmettes
Marseille
HIA du Val de Grace
Paris, 75005
HEGP
Paris, 75908
CHI Poissy/St Germain-en-Laye
Poissy, 78303
CHU de Rouen
Rouen, 76000
Hia Begin
Saint-Mandé, 94163
Hôpital Foch
Suresnes, 92151
CHU Rangueil
Toulouse, 31403
CHU Tours
Tours, 37044
About this study
Official title: One-year Mortality According to the Method of Total Intravenous Anesthesia. A Prospective, Randomized and Multicenter Study
A correlation between deep anesthesia (defined as time with Bispectral Index (BIS) lower than 45) and death within 1 yr after surgery has previously been reported. In order to confirm or refute these findings, the investigators have designed a study which compares two methods of administration for total intravenous anesthesia (propofol and remifentanil):
- manual administration: the anesthesiologists are instructed to maintain the BIS value between 40 and 60.
- closed loop administration: an algorithm is used to maintain the BIS value between 40 and 60.
Based on previous studies, the amount of time that BIS is maintained above 40 is greater when anesthetics agents are administered using closed loop compared with manual administration.
- Conditions
- General Anesthesia
- Being tested
- manual administration of iv anesthetics (propofol and remifentanil) using the Toolbox platform, closed-loop administration of iv anesthetics (propofol and remifentanil) using the Toolbox platform
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
manual administration of iv anesthetics (propofol and remifentanil) using the Toolbox platformDevice
the anesthesiologists are instructed to maintain the BIS values between 40 and 60 throughout anesthesia using target controlled infusion method
closed-loop administration of iv anesthetics (propofol and remifentanil) using the Toolbox platformDevice
an algorithm is used to maintain automatically the BIS values between 40 and 60
| Study group | Role | What they receive |
|---|---|---|
| manual administration of iv anesthetics | Active comparator | Not described Receives: Device: manual administration of iv anesthetics (propofol and remifentanil) using the Toolbox platform |
| closed-loop administration of iv anesthetics | Experimental | Not described Receives: Device: closed-loop administration of iv anesthetics (propofol and remifentanil) using the Toolbox platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate during the first year following anesthesia
Measured: one year after anesthesia
Secondary outcomes (8)
conduct of anesthesia (duration of anesthesia with bispectral index < 45, bispectral index < 40, bispectral index > 60, bispectral index > 65, and burst suppression ratio)
Measured: end of anesthesia
intraoperative awareness
Measured: one month postoperatively
patients' satisfaction in the postanesthesia care unit (nausea, vomiting, shivering)
Measured: end of the stay in the postanesthesia care unit
postoperative complication during the hospital stay (ancillary study)
Measured: one month after anesthesia
major medical events during the first year following anesthesia
Measured: one year after anesthesia
relation between patients' characteristics and mortality rate during the first year following anesthesia
Measured: one year after anesthesia
intraoperative parameters, notably hemodynamic parameters, and their relation between them and mortality rate during the first year following anesthesia
Measured: one year after anesthesia
in-hospital and one month mortality
Measured: one year after anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2010 (estimated)
- Study start13 Sep 2010
- Primary completion20 Feb 2014
- Study completion20 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for General 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 2,044 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
- NCT01198639
- Sponsor's protocol ID
- 2009/30
- Acronym
- ELA
- Status last verified
- Feb 2018
- First submitted
- 9 Sep 2010
- Last updated
- 15 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloe PA, Trillat B, Barvais L, Fischler M. Titration of propofol for anesthetic induction and maintenance guided by the bispectral index: closed-loop versus manual control: a prospective, randomized, multicenter study. Anesthesiology. 2006 Apr;104(4):686-95. doi: 10.1097/00000542-200604000-00012.
PubMed 16571963Cantraine FR, Coussaert EJ. The first object oriented monitor for intravenous anesthesia. J Clin Monit Comput. 2000 Jan;16(1):3-10. doi: 10.1023/a:1009904805940.
PubMed 12578088Lindholm ML, Traff S, Granath F, Greenwald SD, Ekbom A, Lennmarken C, Sandin RH. Mortality within 2 years after surgery in relation to low intraoperative bispectral index values and preexisting malignant disease. Anesth Analg. 2009 Feb;108(2):508-12. doi: 10.1213/ane.0b013e31818f603c.
PubMed 19151279Monk TG, Saini V, Weldon BC, Sigl JC. Anesthetic management and one-year mortality after noncardiac surgery. Anesth Analg. 2005 Jan;100(1):4-10. doi: 10.1213/01.ANE.0000147519.82841.5E.
PubMed 15616043Mahr N, Bouhake Y, Chopard G, Liu N, Boichut N, Chazot T, Claveau M, Vettoretti L, Tio G, Pili-Floury S, Samain E, Besch G. Postoperative Neurocognitive Disorders After Closed-Loop Versus Manual Target Controlled-Infusion of Propofol and Remifentanil in Patients Undergoing Elective Major Noncardiac Surgery: The Randomized Controlled Postoperative Cognitive Dysfunction-Electroencephalographic-Guided Anesthetic Administration Trial. Anesth Analg. 2021 Oct 1;133(4):837-847. doi: 10.1213/ANE.0000000000005278.
PubMed 33181558
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-year Mortality According to the Method of Total Intravenous Anesthesia. A Prospective, Randomized and Multicenter Study
- ClinicalTrials.gov ID
- NCT01198639
- Acronym / sponsor ID
- ELA / 2009/30
- Conditions
- General Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,044 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 13 Sep 2010 (actual)
- Primary completion
- 20 Feb 2014 (actual)
- Study completion
- 20 Feb 2015 (actual)
- First posted
- 10 Sep 2010 (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.
A correlation between deep anesthesia (defined as time with Bispectral Index (BIS) lower than 45) and death within 1 yr after surgery has previously been reported. In order to confirm or refute these findings, the investigators have designed a study which compares two methods of administration for total intravenous anesthesia (propofol and remifentanil):
- manual administration: the anesthesiologists are instructed to maintain the BIS value between 40 and 60.
- closed loop administration: an algorithm is used to maintain the BIS value between 40 and 60.
Based on previous studies, the amount of time that BIS is maintained above 40 is greater when anesthetics agents are administered using closed loop compared with manual administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| manual administration of iv anesthetics | Active comparator | Device: manual administration of iv anesthetics (propofol and remifentanil) using the Toolbox platform |
| closed-loop administration of iv anesthetics | Experimental | Device: closed-loop administration of iv anesthetics (propofol and remifentanil) using the Toolbox platform |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiology patient classification status I, II and III
- patients aged between 50 and 85 years old
- born in France
- surgical procedures lasting more than one hour
Key exclusion criteria (8 listed)
- American Society of Anesthesiology patient classification status IV
- patients born out of France
- pace-maker
- surgical procedure on the skull or avoiding an adequate positioning of the bispectral index electrode dementia, history of central nervous system disease (tumor, vascular event, Parkinson disease, ...)
- psychiatric illness (severe depression or psychosis), patients receiving a psychotropic treatment
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 |
|---|---|---|
| manual administration of iv anesthetics (propofol and remifentanil) using the Toolbox platformthe anesthesiologists are instructed to maintain the BIS values between 40 and 60 throughout anesthesia using target controlled infusion method | Device | manual administration of iv anesthetics |
| closed-loop administration of iv anesthetics (propofol and remifentanil) using the Toolbox platforman algorithm is used to maintain automatically the BIS values between 40 and 60 | Device | closed-loop administration of iv anesthetics |
Primary outcome
Mortality rate during the first year following anesthesia
Time frame: one year after anesthesia
8 secondary outcomes
conduct of anesthesia (duration of anesthesia with bispectral index < 45, bispectral index < 40, bispectral index > 60, bispectral index > 65, and burst suppression ratio)
Time frame: end of anesthesia
intraoperative awareness
Time frame: one month postoperatively
patients' satisfaction in the postanesthesia care unit (nausea, vomiting, shivering)
Time frame: end of the stay in the postanesthesia care unit
postoperative complication during the hospital stay (ancillary study)
Time frame: one month after anesthesia
major medical events during the first year following anesthesia
Time frame: one year after anesthesia
relation between patients' characteristics and mortality rate during the first year following anesthesia
Time frame: one year after anesthesia
intraoperative parameters, notably hemodynamic parameters, and their relation between them and mortality rate during the first year following anesthesia
Time frame: one year after anesthesia
in-hospital and one month mortality
Time frame: one year after anesthesia
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 15 Feb 2018.
- Background: PubMed 16571963Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloe PA, Trillat B, Barvais L, Fischler M. Titration of propofol for anesthetic induction and maintenance guided by the bispectral index: closed-loop versus manual control: a prospective, randomized, multicenter study. Anesthesiology. 2006 Apr;104(4):686-95. doi: 10.1097/00000542-200604000-00012.
- Background: PubMed 12578088Cantraine FR, Coussaert EJ. The first object oriented monitor for intravenous anesthesia. J Clin Monit Comput. 2000 Jan;16(1):3-10. doi: 10.1023/a:1009904805940.
- Results publication: PubMed 19151279Lindholm ML, Traff S, Granath F, Greenwald SD, Ekbom A, Lennmarken C, Sandin RH. Mortality within 2 years after surgery in relation to low intraoperative bispectral index values and preexisting malignant disease. Anesth Analg. 2009 Feb;108(2):508-12. doi: 10.1213/ane.0b013e31818f603c.
- Results publication: PubMed 15616043Monk TG, Saini V, Weldon BC, Sigl JC. Anesthetic management and one-year mortality after noncardiac surgery. Anesth Analg. 2005 Jan;100(1):4-10. doi: 10.1213/01.ANE.0000147519.82841.5E.
- Derived from this study: PubMed 33181558Mahr N, Bouhake Y, Chopard G, Liu N, Boichut N, Chazot T, Claveau M, Vettoretti L, Tio G, Pili-Floury S, Samain E, Besch G. Postoperative Neurocognitive Disorders After Closed-Loop Versus Manual Target Controlled-Infusion of Propofol and Remifentanil in Patients Undergoing Elective Major Noncardiac Surgery: The Randomized Controlled Postoperative Cognitive Dysfunction-Electroencephalographic-Guided Anesthetic Administration Trial. Anesth Analg. 2021 Oct 1;133(4):837-847. doi: 10.1213/ANE.0000000000005278.
Related trials for General Anesthesia
Not yet recruitingObservational study
Diaphragm Ultrasound and Neuromuscular Monitoring for Predicting Early Respiratory Events After Extubation
Residual Neuromuscular Blockade, Diaphragm Dysfunction
Recruiting
Effect of a Brief Educational Intervention on Endotracheal Tube Cuff Pressure
Intubation, Endotracheal Tube Cuff Pressure
Recruiting
Pharyngeal Mucosal Conditioning to Prevent Postoperative Sore Throat in Septoplasty Patients With Severe Nasal Obstruction
Postoperative Sore Throat, Nasal Obstruction
Not yet recruiting
Comparison of Second- and Third-Generation Laryngeal Mask Airway in Pediatric Patients
Airway Management, Anesthesia, General
Active, not recruitingObservational study
Post-Induction Low Cardiac Output Syndrome in Coronary Artery Bypass Graft Surgery
Cardiac Output, Low, Coronary Arterial Disease
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
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing manual administration of iv anesthetics (propofol and remifentanil) using the Toolbox platform and closed-loop administration of iv anesthetics (propofol and remifentanil) using the Toolbox platform in people with General Anesthesia, run by Hopital Foch at 22 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 4 inclusion and 8 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 15 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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?
Mortality rate during the first year following anesthesia (time frame: one year after anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01198639, which also lists 5 linked publications.
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 15 Feb 2018.