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Detection of Consciousness by EEG and Auditory Evoked Potentials

NCT ID: NCT01720615

Last Updated: 2012-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2003-04-30

Brief Summary

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The objective of the present investigation is to analyze EEG and auditory evoked potentials at the transition from consciousness to unconsciousness and vice versa. A set of electroencephalographic and auditory evoked potential parameters should be identified that allows separation of consciousness from unconsciousness (reflected by responsiveness/unresponsiveness to command). The study is based on data of 80 patients undergoing general anesthesia with remifentanil and either sevoflurane or propofol.

Detailed Description

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During the past years, monitoring of anesthetic effects on the main target of anesthesia, the brain, has gained increasing attention. Monitoring of the spontaneous electroencephalogram (EEG) and of auditory evoked potentials (AEP) has been suggested. Even if EEG and AEP reflect effects of anesthetic drugs, a visual interpretation is not expedient. As a consequence, several processing methods have been suggested that reduce the electroencephalogram to a numerical value. In the current study, a set of EEG- and AEP parameters based on different analysis methods is tested with respect to the parameters ability in separating consciousness (reflected by responsiveness to command) from unconsciousness at the transition between these stages. Therefore data of 80 unpremedicated patients undergoing general anesthesia with remifentanil and either sevoflurane or propofol is used. The study period is from induction of anesthesia until patients follow command after surgery and includes a reduction of the hypnotic agent after tracheal intubation until patients follow command. The isolated forearm technique is applied before muscle relaxants are given to maintain the ability to squeeze hand to command.

Conditions

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Anesthesia Electroencephalography/ Drug Effect

Keywords

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EEG AEP Propofol Sevoflurane Remifentanil General anesthesia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Propofol or Sevoflurane

General anesthesia

Group Type NO_INTERVENTION

Propofol / Remifentanil

Intervention Type DRUG

General anesthesia: Loss of consciousness and standard clinical practice

Sevoflurane / Remifentanil

Intervention Type DRUG

General anesthesia: Loss of consciousness and standard clinical practice

Interventions

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Propofol / Remifentanil

General anesthesia: Loss of consciousness and standard clinical practice

Intervention Type DRUG

Sevoflurane / Remifentanil

General anesthesia: Loss of consciousness and standard clinical practice

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* American Society of Anesthesiologists (ASA) physical status 1-2
* Adult patients

Exclusion Criteria

* Patients with contraindications to the study drugs
* psychiatric or neurologic disease
* drug abuse or medication known to affect the central nervous system
* pregnancy
* indication for rapid sequence induction
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technical University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Gerhard Schneider

Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eberhard F Kochs, MD

Role: STUDY_CHAIR

Klinikum rechts der Isar Technische Universität München

Locations

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Technische Universität München, Klinikum rechts der Isar, Department of Anesthesiology

Munich, Bavaria, Germany

Site Status

Countries

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Germany

Other Identifiers

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2001

Identifier Type: -

Identifier Source: org_study_id