Relationship Between Bispectral Index (BIS) and Spectral Entropy (SpEn) During Desflurane Anaesthesia
NCT ID: NCT01868178
Last Updated: 2013-06-04
Study Results
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Basic Information
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COMPLETED
50 participants
OBSERVATIONAL
2008-09-30
2009-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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BIS Spectral Entropy Group
intraoperative monitoring with BIS and Spectral Entropy
BIS and Spectral Entropy
The aim of the study was investigated the effectiveness of Spectral Entropy and BIS in avoiding awareness
Interventions
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BIS and Spectral Entropy
The aim of the study was investigated the effectiveness of Spectral Entropy and BIS in avoiding awareness
Eligibility Criteria
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Inclusion Criteria
* Italian native speakers
Exclusion Criteria
* Acoustic impairment
* Obesity (Body Mass Index \> 30)
* Substance dependence.
30 Years
60 Years
FEMALE
No
Sponsors
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Catholic University of the Sacred Heart
OTHER
Responsible Party
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Germano De Cosmo
PhD
Principal Investigators
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De Cosmo Germano, PhD
Role: PRINCIPAL_INVESTIGATOR
Catholic University of Sacred Heart
Locations
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Catholic University of Sacred Heart
Rome, Rm, Italy
Catholic University
Rome, Rm, Italy
Countries
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References
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Domino KB, Posner KL, Caplan RA, Cheney FW. Awareness during anesthesia: a closed claims analysis. Anesthesiology. 1999 Apr;90(4):1053-61. doi: 10.1097/00000542-199904000-00019.
Heier T, Steen PA. Awareness in anaesthesia: incidence, consequences and prevention. Acta Anaesthesiol Scand. 1996 Oct;40(9):1073-86. doi: 10.1111/j.1399-6576.1996.tb05569.x.
Liu WH, Thorp TA, Graham SG, Aitkenhead AR. Incidence of awareness with recall during general anaesthesia. Anaesthesia. 1991 Jun;46(6):435-7. doi: 10.1111/j.1365-2044.1991.tb11677.x.
O'Connor MF, Daves SM, Tung A, Cook RI, Thisted R, Apfelbaum J. BIS monitoring to prevent awareness during general anesthesia. Anesthesiology. 2001 Mar;94(3):520-2. doi: 10.1097/00000542-200103000-00025.
Brice DD, Hetherington RR, Utting JE. A simple study of awareness and dreaming during anaesthesia. Br J Anaesth. 1970 Jun;42(6):535-42. doi: 10.1093/bja/42.6.535. No abstract available.
Ranta SO, Laurila R, Saario J, Ali-Melkkila T, Hynynen M. Awareness with recall during general anesthesia: incidence and risk factors. Anesth Analg. 1998 May;86(5):1084-9. doi: 10.1097/00000539-199805000-00035.
Ghoneim MM. Incidence of and risk factors for awareness during anaesthesia. Best Pract Res Clin Anaesthesiol. 2007 Sep;21(3):327-43. doi: 10.1016/j.bpa.2007.05.002.
Kissin I. Depth of anesthesia and bispectral index monitoring. Anesth Analg. 2000 May;90(5):1114-7. doi: 10.1097/00000539-200005000-00021. No abstract available.
Paolo Martorano P, Falzetti G, Pelaia P. Bispectral index and spectral entropy in neuroanesthesia. J Neurosurg Anesthesiol. 2006 Jul;18(3):205-10. doi: 10.1097/01.ana.0000206229.38883.d2.
Liu J, Singh H, White PF. Electroencephalographic bispectral index correlates with intraoperative recall and depth of propofol-induced sedation. Anesth Analg. 1997 Jan;84(1):185-9. doi: 10.1097/00000539-199701000-00033.
Other Identifiers
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A 935/2007
Identifier Type: -
Identifier Source: org_study_id
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