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Comparison of Two Electroencephalogram (EEG)-Derived Indices With Electroencephalogram Signals

NCT ID: NCT01077674

Last Updated: 2013-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

65 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Anaesthesia Surgery

Keywords

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Electroencephalogram Entropy BIS Sevoflurane

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Entropy - BIS

Patients undergoing surgery in sevoflurane anaesthesia.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Planned surgery necessitating general anaesthesia
* Expected duration of anaesthesia 30 min or more
* Need of endotracheal intubation
* ASA status 1, 2 or 3

Exclusion Criteria

* 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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tampere University Hospital

OTHER

Sponsor Role collaborator

Arvi Yli-Hankala

OTHER

Sponsor Role lead

Responsible Party

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Arvi Yli-Hankala

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Arvi Yli-Hankala, MD

Role: STUDY_CHAIR

Tampere University Hospital

Locations

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Tampere University Hospital

Tampere, , Finland

Site Status

Countries

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Finland

References

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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.

Reference Type DERIVED
PMID: 26137969 (View on PubMed)

Other Identifiers

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Kotoe_03

Identifier Type: -

Identifier Source: org_study_id