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

This study has suspended participant recruitment.
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris Identifier:
First received: September 13, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
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.

Condition Intervention Phase
Scheduled General Anesthesia
Device: Alaris AEP monitor
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Utility of the Alaris MidLatencyAuditoryEvoked Potentials Monitor to Titrate the Anesthetic-Hypnotic Component of Anesthesia

Resource links provided by NLM:

Further study details as provided by Gustave Roussy, Cancer Campus, Grand Paris:

Primary Outcome Measures:
  • Influence of AEP guided anesthesia on recovery delay

Estimated Enrollment: 128
Study Start Date: February 2003

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00181051

Institut Gustave-Roussy
Villejuif, France, 94800
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Principal Investigator: Michel STRUYS, MD CHU de GENT - BELGIUM
  More Information Identifier: NCT00181051     History of Changes
Other Study ID Numbers: PEA  CSET 2002/948 
Study First Received: September 13, 2005
Last Updated: September 13, 2005
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on May 02, 2016