AnaesthesiaNCT01077674
Comparison of Two Electroencephalogram (EEG)-Derived Indices With Electroencephalogram Signals
An observational study of Anaesthesia and Surgery, run by Arvi Yli-Hankala at 1 site in Finland.
Trial summary
Bispectral Index (BIS) and Entropy indices will be compared with each other, and to raw EEG signals in patients receiving sevoflurane anaesthesia. BIS and Entropy numbers often differ significantly from each other during surgery, and the reason for this has not been studied in detail, therefore remaining only poorly… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Anaesthesia, Surgery
- How many people
- 65 participants
- Where
- 1 siteFinland
- Study dates
- Dec 2009to Mar 2011
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Middle aged and elderly surgical patients
Who may be able to join
- Planned surgery necessitating general anaesthesia
- Expected duration of anaesthesia 30 min or more
- Need of endotracheal intubation
- ASA status 1, 2 or 3
Who cannot join
- Significant disorders of the autonomic or central nervous system
- Family history of malignant hyperthermia
- Clinical history of anaphylactic reaction against inhaled anaesthetics
- Disability to communicate with Finnish language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Bispectral Index and Entropy With Electroencephalogram During Sevoflurane Anaesthesia
Bispectral Index (BIS) and Entropy indices will be compared with each other, and to raw EEG signals in patients receiving sevoflurane anaesthesia. BIS and Entropy numbers often differ significantly from each other during surgery, and the reason for this has not been studied in detail, therefore remaining only poorly understood. BIS and Entropy, together with multi-channel EEG, will be collected and analyzed later on. Course of anaesthesia and surgery will be annotated. All relevant information from anaesthesia monitor will be collected on computer.
- Conditions
- Anaesthesia, Surgery
- Keywords
- Electroencephalogram, Entropy, BIS, Sevoflurane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Entropy - BIS | Patients undergoing surgery in sevoflurane anaesthesia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphology of electroencephalogram during discrepancy between Entropy and BIS index values
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2010 (estimated)
- Study startDec 2009
- Primary completionMar 2011
- Study completionMar 2011
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 AnaesthesiaStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arvi Yli-Hankala
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University Hospital
- Responsible party
- Sponsor-investigator, Arvi Yli-Hankala, Tampere University Hospital
- Investigators
- Arvi Yli-Hankala, MD, Study chair, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01077674
- Sponsor's protocol ID
- Kotoe_03
- Status last verified
- Oct 2013
- First submitted
- 26 Feb 2010
- Last updated
- 9 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Aho AJ, Kamata K, Jantti V, Kulkas A, Hagihira S, Huhtala H, Yli-Hankala A. Comparison of Bispectral Index and Entropy values with electroencephalogram during surgical anaesthesia with sevoflurane. Br J Anaesth. 2015 Aug;115(2):258-66. doi: 10.1093/bja/aev206. Epub 2015 Jul 1.
PubMed 26137969
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Bispectral Index and Entropy With Electroencephalogram During Sevoflurane Anaesthesia
- ClinicalTrials.gov ID
- NCT01077674
- Acronym / sponsor ID
- Kotoe_03
- Conditions
- Anaesthesia, Surgery
- Keywords
- Electroencephalogram, Entropy, BIS, Sevoflurane
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Arvi Yli-HankalaUniversity, hospital or other
- Collaborators
- Tampere University Hospital
- Study start
- Dec 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 1 Mar 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.
Bispectral Index (BIS) and Entropy indices will be compared with each other, and to raw EEG signals in patients receiving sevoflurane anaesthesia. BIS and Entropy numbers often differ significantly from each other during surgery, and the reason for this has not been studied in detail, therefore remaining only poorly understood. BIS and Entropy, together with multi-channel EEG, will be collected and analyzed later on. Course of anaesthesia and surgery will be annotated. All relevant information from anaesthesia monitor will be collected on computer.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Entropy - BIS | – | –Patients undergoing surgery in sevoflurane anaesthesia. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Middle aged and elderly surgical patients
Key inclusion criteria (4 listed)
- Planned surgery necessitating general anaesthesia
- Expected duration of anaesthesia 30 min or more
- Need of endotracheal intubation
- ASA status 1, 2 or 3
Key exclusion criteria (4 listed)
- Significant disorders of the autonomic or central nervous system
- Family history of malignant hyperthermia
- Clinical history of anaphylactic reaction against inhaled anaesthetics
- Disability to communicate with Finnish language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Morphology of electroencephalogram during discrepancy between Entropy and BIS index values
Time frame: 15 minutes
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 9 Oct 2013.
- Derived from this study: PubMed 26137969Aho AJ, Kamata K, Jantti V, Kulkas A, Hagihira S, Huhtala H, Yli-Hankala A. Comparison of Bispectral Index and Entropy values with electroencephalogram during surgical anaesthesia with sevoflurane. Br J Anaesth. 2015 Aug;115(2):258-66. doi: 10.1093/bja/aev206. Epub 2015 Jul 1.
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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.
Arvi Yli-Hankala, MD study chair
Tampere University Hospital
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 Anaesthesia and Surgery, run by Arvi Yli-Hankala at 1 site in Finland.
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 4 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 9 Oct 2013. 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 Finland. 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?
Morphology of electroencephalogram during discrepancy between Entropy and BIS index values (time frame: 15 minutes). 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 NCT01077674, 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 9 Oct 2013.