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

Gustave Roussy

Status and phase

Suspended

Phase 3

Conditions

Scheduled General Anesthesia

Treatments

Device: Alaris AEP monitor

Study type

Interventional

Funder types

Other

Identifiers

NCT00181051

CSET 2002/948

PEA

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.