NCT00181051SuspendedPhase 3
Clinical Utility of the Alaris MidLatencyAuditoryEvoked Potentials Monitor to Titrate the Anesthetic-Hypnotic Component of Anesthesia
Gustave Roussy, Cancer Campus, Grand Paris1 site in 1 country128 target enrollmentStarted: February 1, 2003Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Suspended
- Enrollment
- 128
- Locations
- 1
- Primary Endpoint
- Influence of AEP guided anesthesia on recovery delay
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- 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.
Outcomes
Primary Outcomes
Influence of AEP guided anesthesia on recovery delay
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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