Relationship Between Bispectral Index (BIS) and Spectral Entropy (SpEn) During Desflurane Anaesthesia

May 30, 2013 updated by: Germano De Cosmo, Catholic University of the Sacred Heart
The aim of this study was to estimate the relationship between BIS and Spectral Entropy values and any explicit or implicit memory or dreams recall during desflurane anaesthesia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

During the last decade, an increasing number of monitor systems were developed designed to assess the depth of anesthesia.

Awareness is a rare occurrence of explicit recalls during anaesthesia with an incidence of 0,18% and the use of cerebral monitoring prevents about 50% of these events.

Different stages of awareness should be defined and implicit memorization is subconscious awareness without explicit recall and possible implicit recall with an incidence greater than awareness.

To assess implicit recalls, a large number of test can be used, for example the "word stem completation test" and the "free recall association test". These result easy to use and reliable in detect implicit memory.

Bispectral Index (BIS) and Spectral Entropy (SpEn) has been proposed, in recent years, as electroencephalographic monitors of anaesthesia depth.

The bispectral index is a monitor of anaesthetic depth approved by the Food and Drug Administration in the USA. The BIS monitor reports a dimensionless number between 0 (complete EEG inactivity) and 100 (awake state); BIS values from 40 to 60 are thought to be suitable for general anaesthesia. Spectral Entropy acquires the electroencephalograph (EEG) and frontal electromyography (FEMG) signals which are processed into three parameters: State Entropy (SE), Response Entropy (RE) and Burst Suppression Ratio (BSR).

SE is computed over the EEG dominant part of the spectrum (0.8-32 Hz), and therefore primarily should reflect the cortical state of the patient and results useful to assess hypnotic effects of drugs .

RE is computed over a frequency range from 0.8 to47 Hz. It includes both the EEG-dominant and EMG-dominant part of the spectrum . The SE and RE values below 60 correlate with a low probability of consciousness. Also Bispectral Index provides BRS, an evaluation of burst suppression in which cerebral activity results suppressed.

BIS and Spectral Entropy are intended to decrease the risk of intraoperative awareness and to enable the anesthetist to reduce risk of the under- and overdosing of anesthetic agents and to ensure faster and more predictable wake-up and extubation.

Previous studies result contrasting in the correlation between these devices with lack in evaluation of implicit memory.

The aim of this study was to estimate the relationship between BIS and Spectral Entropy values and any explicit or implicit memory or dreams recall during desflurane anaesthesia.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Rm
      • Rome, Rm, Italy, 00168
        • Catholic University Of Sacred Heart
      • Rome, Rm, Italy, 00168
        • Catholic University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

female patients, aged 30-60 years , scheduled for minor elective surgery lasts between 1 and 3 hours were enrolled.

Description

Inclusion Criteria:

  • American society of anesthesiologist physical status I-II
  • Italian native speakers

Exclusion Criteria:

  • Psychiatric or neurologic diseases
  • Acoustic impairment
  • Obesity (Body Mass Index > 30)
  • Substance dependence.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
BIS Spectral Entropy Group
intraoperative monitoring with BIS and Spectral Entropy
Device: BIS and Spectral Entropy
The aim of the study was investigated the effectiveness of Spectral Entropy and BIS in avoiding awareness

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
BIS index
Time Frame: change from baseline at 15 min
change from baseline at 15 min

Secondary Outcome Measures

Outcome Measure
Time Frame
entropy values
Time Frame: 24 h after emergency from anaesthesia
24 h after emergency from anaesthesia

Other Outcome Measures

Outcome Measure
Time Frame
explicit and implicit memory and dreams recall.
Time Frame: after 24 h
after 24 h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catholic University of the Sacred Heart

Investigators

  • Principal Investigator: De Cosmo Germano, PhD, Catholic University Of Sacred Heart

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

November 12, 2012

First Submitted That Met QC Criteria

May 30, 2013

First Posted (Estimate)

June 4, 2013

Study Record Updates

Last Update Posted (Estimate)

June 4, 2013

Last Update Submitted That Met QC Criteria

May 30, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A 935/2007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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