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Completed

NCT Number: NCT01868178

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

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.

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Key information

Age range

30 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

Catholic University, Rome, Rm, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BIS and Spectral Entropy

Device

The aim of the study was investigated the effectiveness of Spectral Entropy and BIS in avoiding awareness

Primary outcomes

  1. BIS index

    Time frame: change from baseline at 15 min

Secondary outcomes

  1. entropy values

    Time frame: 24 h after emergency from anaesthesia

Other outcomes

  1. explicit and implicit memory and dreams recall.

    Time frame: after 24 h

Sponsors and collaborators

Lead sponsor

Catholic University of the Sacred Heart

Other

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 4, 2013
Registry last updated
Jun 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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