Clinical Trial: Awareness During Blended Anaesthesia
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Relationships Between Bispectral Index (BIS), Implicit Memory Dream Recall and MAC in Blended Anaesthesia
Brief Summary: 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.
Detailed Summary:
The decreased responsiveness to stimulation defines depth of anaesthesia which is a balance between effects of anaesthetic drugs and surgical stimulations.
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 a
Sponsor: Germano De Cosmo
Current Primary Outcome: correlation between BIS and free association test score [ Time Frame: every 15 min during anaesthesia and 24 h after emergency from anaesthesia ]
Original Primary Outcome: Same as current
Current Secondary Outcome: MAC of sevoflurane necessary to avoid awareness [ Time Frame: 24 h after emergency from anaesthesia ]
Original Secondary Outcome: Same as current
Information By: Catholic University of the Sacred Heart
Dates:
Date Received: November 12, 2012
Date Started: September 2005
Date Completion:
Last Updated: February 25, 2013
Last Verified: February 2013
