Clinical Utility of the Alaris MidLatencyAuditoryEvoked Potentials Monitor to Titrate the Anesthetic-Hypnotic Component of Anesthesia
Phase 3
Suspended
- Conditions
- Scheduled General Anesthesia
- Registration Number
- NCT00181051
- Lead Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 128
Inclusion Criteria
- ASA status I-II patients
- aged 18 - 65 years
- scheduled for general surgery (except laparoscopic interventions) lasting longer than 1 hour.
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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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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Influence of AEP guided anesthesia on recovery delay
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Institut Gustave-Roussy
🇫🇷Villejuif, France