aepEX™ Depth of Anaesthesia Monitoring in Children.
Completed
- Conditions
- Depth of AnaesthesiaAuditory Evoked PotentialsPaediatric AnaesthesiaBIS monitoraepEX
- Registration Number
- NL-OMON27038
- Lead Sponsor
- Erasmus University Medical Center, RotterdamDep. of AnaesthesiaPaediatric Anaesthesia Unit - Sophia Children's Hospital
- Brief Summary
Cheung YM, Scoones GP, Hoeks SE, Stolker RJ, Weber F. Evaluation of the aepEX monitor of hypnotic depth in pediatric patients receiving propofol-remifentanil anesthesia. Paediatric anaesthesia. 2013;23(10):891-7. <br><br> Cheung YM, Scoones GP, Stolker RJ, Weber F. Evaluation of the auditory evoked potentials derived aepEX() as a measure of hypnotic depth in pediatric patients receiving sevoflurane-remifentanil anesthesia. Paediatric anaesthesia. 2014;24(7):760-5.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 225
Inclusion Criteria
1. Age 1-18 years;
2. General anaesthesia;
Exclusion Criteria
1. Significant hearing impairment;
2. Intake of drugs affecting the EEG;
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The performance of the aepEX™ as a measure of DoH in paediatric patients (1-18 years old), anaesthetised with propofol, sevoflurane or desflurane. The accuracy of the aepEX™ will be expressed in Pk-values.
- Secondary Outcome Measures
Name Time Method The effects of different propofol concentrations, (applied by Target Controlled Infusion), sevoflurane and desflurane concentrations on the aepEX, the University of Michigan Sedation Scale (UMSS), BIS and hemodynamic variables.<br><br /><br /><br>MLAEP latencies and amplitudes will be extracted from the raw-MLAEP waveforms and linked to propofol plasma, sevoflurane and desflurane concentrations and the UMSS.