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

This study has suspended participant recruitment.
Sponsor:
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier:
NCT00181051
First received: September 13, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

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

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
  Eligibility

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

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00181051

Locations
France
Institut Gustave-Roussy
Villejuif, France, 94800
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Investigators
Principal Investigator: Michel STRUYS, MD CHU de GENT - BELGIUM
  More Information

No publications provided

ClinicalTrials.gov 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:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014