AnesthesiaNCT00910416
The Comparability of Bispectral Index and Neurosense During Anesthesia
An observational study of Anesthesia, run by Hopital Foch at 1 site in France.
Trial summary
The assessment of anesthesia depth was based, until recently, on the evolution of hemodynamic parameters. Nowadays it can be evaluated by several monitoring methods, derived from electroencephalogram analysis, namely the Bispectral Index (Aspect Medical Systems, Newton, USA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- propofol, remifentanil, atracurium, propofol, remifentanil, atracurium, sevoflurane and EEG monitoring
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- May 2009to Dec 2010
- Phase
- Observational
- 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
Study population: Surgical patients
Who may be able to join
- Patients requiring either intravenous anesthesia or balanced anesthesia (including sevoflurane)
Who cannot join
- Pregnant women,
- Allergy to propofol, remifentanil, morphine, muscle relaxant, or to a component,
- Hypersensibility to sufentanil, remifentanil or to a derivate of fentanyl,
- History of neurological disorder or central brain lesion, of muscle disease,
- Patient carrying a pacemaker,
- Patients receiving a psychotropic treatment or a morphine agonist-antagonist,
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- Alcoholic patients and patients taking opiates,
- Surgery with extracorporeal circulation,
- Surgical position incompatible with an adequate positioning of the probe.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Comparability of Bispectral Index and Neurosense During Total Intravenous Anesthesia and Balanced Anesthesia
The assessment of anesthesia depth was based, until recently, on the evolution of hemodynamic parameters. Nowadays it can be evaluated by several monitoring methods, derived from electroencephalogram analysis, namely the Bispectral Index (Aspect Medical Systems, Newton, USA). A new modality is currently under development: the NeuroSENSE (Cleveland Medical Devices Inc., Cleveland, OH 44103, USA). The goal of this study is to compare both monitoring modalities during anesthesia.
- Conditions
- Anesthesia
- Being tested
- propofol, remifentanil, atracurium, propofol, remifentanil, atracurium, sevoflurane, EEG monitoring
- Keywords
- Anesthesia, Monitoring, Intraoperative, Electroencephalography/*drug effects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofol, remifentanil, atracuriumDrug
propofol, remifentanil, atracurium dosages are adapted according to clinician's judgment
propofol, remifentanil, atracurium, sevofluraneDrug
dosages are adapted according to clinician's judgment
EEG monitoringDevice
simultaneous monitoring with Bis and Neurosense
| Study group | Role | What they receive |
|---|---|---|
| patients receiving iv anesthesia | Not described Receives: Drug: propofol, remifentanil, atracurium; Device: EEG monitoring | |
| patients receiving balanced anesthesia | Not described Receives: Drug: propofol, remifentanil, atracurium, sevoflurane; Device: EEG monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance between pairs of Bispectral Index and Neurosense indices during maintenance of anesthesia
Statistical analysis of concordance
Measured: at the end of each case
Secondary outcomes (1)
Concordance between pairs of Bispectral Index and Neurosense indices during induction and emergence
Statistical analysis of concordance
Measured: at the end of each case
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2009 (estimated)
- Study startMay 2009
- Primary completionDec 2010
- Study completionDec 2010
Why it stopped: Differences between BIS and Neurosense are important. This study can be terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 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
- NCT00910416
- Sponsor's protocol ID
- 2008/22
- Status last verified
- Sep 2016
- First submitted
- 27 May 2009
- Last updated
- 23 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Zikov T, Bibian S, Dumont GA, Huzmezan M, Ries CR. Quantifying cortical activity during general anesthesia using wavelet analysis. IEEE Trans Biomed Eng. 2006 Apr;53(4):617-32. doi: 10.1109/TBME.2006.870255.
PubMed 16602568
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparability of Bispectral Index and Neurosense During Total Intravenous Anesthesia and Balanced Anesthesia
- ClinicalTrials.gov ID
- NCT00910416
- Acronym / sponsor ID
- 2008/22
- Conditions
- Anesthesia
- Keywords
- Anesthesia, Monitoring, Intraoperative, Electroencephalography/*drug effects
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Differences between BIS and Neurosense are important. This study can be terminated.
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 29 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 assessment of anesthesia depth was based, until recently, on the evolution of hemodynamic parameters. Nowadays it can be evaluated by several monitoring methods, derived from electroencephalogram analysis, namely the Bispectral Index (Aspect Medical Systems, Newton, USA). A new modality is currently under development: the NeuroSENSE (Cleveland Medical Devices Inc., Cleveland, OH 44103, USA). The goal of this study is to compare both monitoring modalities during anesthesia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients receiving iv anesthesia | – | Drug: propofol, remifentanil, atracurium, Device: EEG monitoring |
| patients receiving balanced anesthesia | – | Drug: propofol, remifentanil, atracurium, sevoflurane, Device: EEG monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Surgical patients
Key inclusion criteria (1 listed)
- Patients requiring either intravenous anesthesia or balanced anesthesia (including sevoflurane)
Key exclusion criteria (9 listed)
- Pregnant women,
- Allergy to propofol, remifentanil, morphine, muscle relaxant, or to a component,
- Hypersensibility to sufentanil, remifentanil or to a derivate of fentanyl,
- History of neurological disorder or central brain lesion, of muscle disease,
- Patient carrying a pacemaker,
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 |
|---|---|---|
| propofol, remifentanil, atracuriumpropofol, remifentanil, atracurium dosages are adapted according to clinician's judgment | Drug | patients receiving iv anesthesia |
| propofol, remifentanil, atracurium, sevofluranedosages are adapted according to clinician's judgment | Drug | patients receiving balanced anesthesia |
| EEG monitoringsimultaneous monitoring with Bis and Neurosense | Device | patients receiving balanced anesthesia, patients receiving iv anesthesia |
Primary outcome
Concordance between pairs of Bispectral Index and Neurosense indices during maintenance of anesthesia
Time frame: at the end of each case
Statistical analysis of concordance
1 secondary outcome
Concordance between pairs of Bispectral Index and Neurosense indices during induction and emergence
Time frame: at the end of each case
Results and safety
The study was stopped early (reason given: Differences between BIS and Neurosense are important. This study can be terminated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2016.
- Background: PubMed 16602568Zikov T, Bibian S, Dumont GA, Huzmezan M, Ries CR. Quantifying cortical activity during general anesthesia using wavelet analysis. IEEE Trans Biomed Eng. 2006 Apr;53(4):617-32. doi: 10.1109/TBME.2006.870255.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, run by Hopital Foch at 1 site 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 9 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: stopped early, as of the sponsor's last update on 23 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early (reason given: Differences between BIS and Neurosense are important. This study can be terminated.). Results are not available in the source record.
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?
Concordance between pairs of Bispectral Index and Neurosense indices during maintenance of anesthesia (time frame: at the end of each case). 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 NCT00910416, which also lists 1 linked publication.
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 23 Sep 2016.