Scheduled General Anesthesia Clinical Trial
Official title:
Clinical Utility of the Alaris MidLatencyAuditoryEvoked Potentials Monitor to Titrate the Anesthetic-Hypnotic Component of Anesthesia
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.
| Status | Suspended |
| Enrollment | 128 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | Institut Gustave-Roussy | Villejuif |
| Lead Sponsor | Collaborator |
|---|---|
| Gustave Roussy, Cancer Campus, Grand Paris |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Influence of AEP guided anesthesia on recovery delay |