Anesthesia, GeneralNCT00391963
Comparison of the Bispectral Index and the Entropy of the Electroencephalogram During Total Intravenous Anesthesia
An observational study of Anesthesia, General, run by Hopital Foch at 2 sites in France.
Trial summary
To compare Bispectral index and entropy during maintenance of anesthesia 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?
- Bispectral index, Entropy
- Type of treatment
- Medical device
- How many people
- 84 participants
- Where
- 2 sitesFrance
- Study dates
- Jun 2006to Apr 2007
- 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
Who may be able to join
- age > 18 years,
- American Society of Anesthesiologists physical status 1-3,
- surgery under general anesthesia using propofol, sufentanil, and a relaxant agent,
- surgery lasting more than one hour,
- tracheal extubation planned at end of surgery
Who cannot join
- pregnant women,
- allergy to propofol,
- neurological or muscular disorder,
- treatment with opioids or any psychoactive medication,
- cardiac surgery,
- thyroid disorder,
- emergency surgery,
- prone or lateral decubitus position (difficulty to have a correct probe position)
Trial locations and contacts
2 sites in 1 country.
France2 sites
Dept of Anesthesia and Intensive Care, Hôpital Beaujon
Clichy, 92110
Dept of Anesthesiology, Hôpital Foch
Suresnes, 92150
About this study
To compare Bispectral index and entropy during maintenance of anesthesia
Read the detailed description
Several monitors are currently proposed to evaluate the depth of hypnosis. Among them, Bispectral Index (BIS) is a well known and widely used parameter derived from the patient's electroencephalograph (EEG). Spectral entropy relies on the extent of disorder in both EEG and electromyography (EMG) signals and returns 2 values: State Entropy (SE) and Response Entropy. SE is computed over the frequency range of 0.8-32 Hz and reflects the level of hypnosis while Response Entropy is computed over the frequency range of 0.8-47 Hz and reflects also EMG activity. BIS and SE are dimensionless numbers scaled from 100 to 0 for BIS and from 91 to 0 for SE.
The BIS and Entropy manufacturers claim that adequate level of anesthesia is defined by a BIS or SE value between 40 and 60. But some observations have shown that the monitors provided different information. These observations led us to carry out this prospective observational study designed to study the comparability between BIS and SE during the maintenance period of propofol-sufentanil anesthesia.
- Conditions
- Anesthesia, General
- Being tested
- Bispectral index, Entropy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bispectral index, EntropyDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2006 (estimated)
- Study startJun 2006
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 84 participants
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Investigators
- Marc Fischler, MD, Principal investigator, Hôpital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00391963
- Sponsor's protocol ID
- Foch-2
- Status last verified
- Jan 2009
- First submitted
- 24 Oct 2006
- Last updated
- 15 Jan 2009
- Results posted
- No
Publications
Schmidt GN, Bischoff P, Standl T, Hellstern A, Teuber O, Schulte Esch J. Comparative evaluation of the Datex-Ohmeda S/5 Entropy Module and the Bispectral Index monitor during propofol-remifentanil anesthesia. Anesthesiology. 2004 Dec;101(6):1283-90. doi: 10.1097/00000542-200412000-00007.
PubMed 15564934Vanluchene AL, Vereecke H, Thas O, Mortier EP, Shafer SL, Struys MM. Spectral entropy as an electroencephalographic measure of anesthetic drug effect: a comparison with bispectral index and processed midlatency auditory evoked response. Anesthesiology. 2004 Jul;101(1):34-42. doi: 10.1097/00000542-200407000-00008.
PubMed 15220769Aime I, Gayat E, Fermanian C, Cook F, Peuch C, Laloe PA, Mantz J, Fischler M. Effect of age on the comparability of bispectral and state entropy indices during the maintenance of propofol-sufentanil anaesthesia. Br J Anaesth. 2012 Apr;108(4):638-43. doi: 10.1093/bja/aer457. Epub 2012 Jan 17.
PubMed 22258203
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Bispectral Index and the Entropy of the Electroencephalogram During Total Intravenous Anesthesia
- ClinicalTrials.gov ID
- NCT00391963
- Acronym / sponsor ID
- Foch-2
- Conditions
- Anesthesia, General
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- Jun 2006
- Study completion
- Apr 2007 (actual)
- First posted
- 25 Oct 2006 (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.
To compare Bispectral index and entropy during maintenance of anesthesia
Detailed description
Several monitors are currently proposed to evaluate the depth of hypnosis. Among them, Bispectral Index (BIS) is a well known and widely used parameter derived from the patient's electroencephalograph (EEG). Spectral entropy relies on the extent of disorder in both EEG and electromyography (EMG) signals and returns 2 values: State Entropy (SE) and Response Entropy. SE is computed over the frequency range of 0.8-32 Hz and reflects the level of hypnosis while Response Entropy is computed over the frequency range of 0.8-47 Hz and reflects also EMG activity. BIS and SE are dimensionless numbers scaled from 100 to 0 for BIS and from 91 to 0 for SE.
The BIS and Entropy manufacturers claim that adequate level of anesthesia is defined by a BIS or SE value between 40 and 60. But some observations have shown that the monitors provided different information. These observations led us to carry out this prospective observational study designed to study the comparability between BIS and SE during the maintenance period of propofol-sufentanil anesthesia.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age > 18 years,
- American Society of Anesthesiologists physical status 1-3,
- surgery under general anesthesia using propofol, sufentanil, and a relaxant agent,
- surgery lasting more than one hour,
- tracheal extubation planned at end of surgery
Key exclusion criteria (8 listed)
- pregnant women,
- allergy to propofol,
- neurological or muscular disorder,
- treatment with opioids or any psychoactive medication,
- cardiac surgery,
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 |
|---|---|---|
| Bispectral index, Entropy | Device | – |
Primary outcome
Not reported in the source record.
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 Jan 2009.
- Background: PubMed 15564934Schmidt GN, Bischoff P, Standl T, Hellstern A, Teuber O, Schulte Esch J. Comparative evaluation of the Datex-Ohmeda S/5 Entropy Module and the Bispectral Index monitor during propofol-remifentanil anesthesia. Anesthesiology. 2004 Dec;101(6):1283-90. doi: 10.1097/00000542-200412000-00007.
- Background: PubMed 15220769Vanluchene AL, Vereecke H, Thas O, Mortier EP, Shafer SL, Struys MM. Spectral entropy as an electroencephalographic measure of anesthetic drug effect: a comparison with bispectral index and processed midlatency auditory evoked response. Anesthesiology. 2004 Jul;101(1):34-42. doi: 10.1097/00000542-200407000-00008.
- Derived from this study: PubMed 22258203Aime I, Gayat E, Fermanian C, Cook F, Peuch C, Laloe PA, Mantz J, Fischler M. Effect of age on the comparability of bispectral and state entropy indices during the maintenance of propofol-sufentanil anaesthesia. Br J Anaesth. 2012 Apr;108(4):638-43. doi: 10.1093/bja/aer457. Epub 2012 Jan 17.
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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 principal investigator
Hôpital Foch
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, General, run by Hopital Foch at 2 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 5 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 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00391963, which also lists 3 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 Jan 2009.