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

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

Status
Suspended
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00181051
Enrollment
128
Registered
2005-09-16
Start date
2003-02-28
Completion date
Unknown
Last updated
2005-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scheduled General Anesthesia

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.

Interventions

DEVICEAlaris AEP monitor

Sponsors

Gustave Roussy, Cancer Campus, Grand Paris
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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.

Design outcomes

Primary

MeasureTime frame
Influence of AEP guided anesthesia on recovery delay

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026