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Completed

NCT Number: NCT01800578

Awareness During Blended Anaesthesia

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.

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Key information

About this study

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 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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

native Italian speakers American society of anaesthesiologist physical status I-II -

Exclusion criteria

refusal of placement of epidural catheter neurological or psychiatric diseases hearing impairment use of drugs know to affect central nervous system coagulopathy heart conditions infections allergy to local anaesthetics liver or renal disease

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Treatment and study plan

monitor for depth of hypnosis

Device

evaluation of depth of hypnosis

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Primary outcomes

  1. correlation between BIS and free association test score

    Time frame: every 15 min during anaesthesia and 24 h after emergency from anaesthesia

Secondary outcomes

  1. MAC of sevoflurane necessary to avoid awareness

    Time frame: 24 h after emergency from anaesthesia

Sponsors and collaborators

Lead sponsor

Germano De Cosmo

Other

Registry information

Official study title

Relationships Between Bispectral Index (BIS), Implicit Memory Dream Recall and MAC in Blended Anaesthesia

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Feb 27, 2013
Registry last updated
Feb 27, 2013

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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