Clinical Utility of the Alaris MidLatencyAuditoryEvoked Potentials Monitor to Titrate the Anesthetic-Hypnotic Component of Anesthesia

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

SUSPENDED

Clinical Phase

PHASE3

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Brief Summary

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Index computed in real time from Auditory Evoked Potentials have been described parallel to depth of anesthesia. The goal of the study was to compare general anesthesia guided on Auditory Evoked Potentials monitoring to standrad practice in order to assess if AEP monitoring can improve recovery delay (main criteria) or intraoperative hemodynamic stability (secondary criteria). Patients were randomized in 2 groups, stratified by center. Group I : AEP guided anesthesia, Group II: Blind AEP record, standard practice.

Detailed Description

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Conditions

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Scheduled General Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Alaris AEP monitor

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* ASA status I-II patients
* aged 18 - 65 years
* scheduled for general surgery (except laparoscopic interventions) lasting longer than 1 hour.

Exclusion Criteria

* Body weight \< 70% or \> 150% ideal body weight
* neurological disorder and hearing disorders (being not able to communicate with the patient in a normal tone)
* use of any medication interfering with pharmacological effect of the study including alcohol misuse or drugs.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Michel STRUYS, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de GENT - BELGIUM

Locations

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Institut Gustave-Roussy

Villejuif, , France

Site Status

Countries

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France

Other Identifiers

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CSET 2002/948

Identifier Type: -

Identifier Source: secondary_id

PEA