Study Results
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Basic Information
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COMPLETED
36 participants
OBSERVATIONAL
2005-09-30
2009-02-28
Brief Summary
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Detailed Description
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Awareness is a rare occurrence with an incidence of 0,1-0,2 % , defined as postoperative recall of events occurring during general anaesthesia.
Different stages of awareness should be defined: conscious awareness with explicit recalls with pain; conscious awareness with explicit recalls without pain; conscious awareness without explicit recall and possible implicit recall; subconscious awareness without explicit recall and possible implicit recall; no awareness .
This memory can be traumatic and may result in developing a chronic posttraumatic stress disorder (PTSD) in more than half of subjects .
Some cases of awareness are caused by inadequate anesthesia and are potentially avoidable through the assessment of depth of hypnosis by an intraoperative monitoring , especially when muscle relaxants are used.
The Bispectral Index ( BIS ), one of the devices designed to monitor brain activity, through a proprietary algorithm , elaborates EEG and provides an index of hypnotic level.
Thus, several variables, derived from EEG time and frequency domain, are combined into a single index indicating the patient's level of consciousness.
A range between 40 and 60, during surgery, permits both to prevent awareness and to reduce the dose of anesthetic agent administered .
In this study, during major abdominal surgery, an epidural analgesia was performed to suppress afferent noxious stimuli and combined with a general anaesthesia based on halogenates.
Thereby the aim of this study was to estimate the relations between Bispectral Index values and explicit or implicit memory or dreams during two different minimal alveolar concentration (MAC) of sevoflurane in patients undergoing blended anaesthesia for major abdominal surgery and ,in this way, estimate the possibility to reduce, in presence of a deep analgesia, like epidural analgesia, the requirement of halogenated volatile anesthetics.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Bispectral Index Group
monitor for depth of hypnosis
evaluation of depth of hypnosis
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Interventions
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monitor for depth of hypnosis
evaluation of depth of hypnosis
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
70 Years
ALL
No
Sponsors
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Germano De Cosmo
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
Locations
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Catholic University of Sacred Heart
Rome, Rm, Italy
Countries
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References
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Wong CS. What's the matter of depth of anesthesia? Acta Anaesthesiol Sin. 2001 Mar;39(1):1-2. No abstract available.
Sandin RH, Enlund G, Samuelsson P, Lennmarken C. Awareness during anaesthesia: a prospective case study. Lancet. 2000 Feb 26;355(9205):707-11. doi: 10.1016/S0140-6736(99)11010-9.
Schwender D, Klasing S, Daunderer M, Madler C, Poppel E, Peter K. [Awareness during general anesthesia. Definition, incidence, clinical relevance, causes, avoidance and medicolegal aspects]. Anaesthesist. 1995 Nov;44(11):743-54. doi: 10.1007/s001010050209. German.
Osterman JE, Hopper J, Heran WJ, Keane TM, van der Kolk BA. Awareness under anesthesia and the development of posttraumatic stress disorder. Gen Hosp Psychiatry. 2001 Jul-Aug;23(4):198-204. doi: 10.1016/s0163-8343(01)00142-6.
Baars BJ. The brain basis of a "consciousness monitor": scientific and medical significance. Conscious Cogn. 2001 Jun;10(2):159-64; discussion 246-58. doi: 10.1006/ccog.2001.0510.
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.
Ekman A, Lindholm ML, Lennmarken C, Sandin R. Reduction in the incidence of awareness using BIS monitoring. Acta Anaesthesiol Scand. 2004 Jan;48(1):20-6. doi: 10.1111/j.1399-6576.2004.00260.x.
Aceto P, Valente A, Gorgoglione M, Adducci E, De Cosmo G. Relationship between awareness and middle latency auditory evoked responses during surgical anaesthesia. Br J Anaesth. 2003 May;90(5):630-5. doi: 10.1093/bja/aeg113.
Other Identifiers
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A1044/2001
Identifier Type: -
Identifier Source: org_study_id
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