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

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ClinicalTrials.gov Identifier: NCT00181051
Recruitment Status : Suspended
First Posted : September 16, 2005
Last Update Posted : September 16, 2005
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Scheduled General Anesthesia Device: Alaris AEP monitor Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Utility of the Alaris MidLatencyAuditoryEvoked Potentials Monitor to Titrate the Anesthetic-Hypnotic Component of Anesthesia
Study Start Date : February 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Arms and Interventions


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00181051     History of Changes
Other Study ID Numbers: PEA
CSET 2002/948
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: September 16, 2005
Last Verified: September 2005

Additional relevant MeSH terms:
Anesthetics
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs