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aepEX™ Depth of Anaesthesia Monitoring in Children.


- candidate number10148
- NTR NumberNTR2983
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-jul-2011
- Secondary IDs2011-104 MEC Erasmus MC
- Public TitleaepEX™ Depth of Anaesthesia Monitoring in Children.
- Scientific TitleEvaluation of the Applicability and Reliability of the Mid-Latency Auditory Evoked Potentials derived aepEX™ as a Measure of Anaesthetic Depth in Paediatric Patients.
- ACRONYMaepEX paediatric
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedChildren, Depth of Anaesthesia, Auditory Evoked Potentials, BIS monitor, aepEX
- Inclusion criteria1. Age 1-18 years;
2. General anaesthesia;
3. Planned elective surgery.
- Exclusion criteria1. Significant hearing impairment;
2. Intake of drugs affecting the EEG;
3. Having a disorder affecting the EEG;
4. Allergy for propofol, remifentanil, sevoflurane and/or desflurane;
5. Planned PICU admission post-operatively with ventilatory support and sedation;
6. Unable to obtain written informed consent.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 12-jul-2011
- planned closingdate1-okt-2013
- Target number of participants225
- InterventionsN/A
- Primary outcomeThe 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 outcomeThe 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.

MLAEP latencies and amplitudes will be extracted from the raw-MLAEP waveforms and linked to propofol plasma, sevoflurane and desflurane concentrations and the UMSS.
- TimepointsDuring anaesthesia, including induction and emergence.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES Y.M. Cheung
- CONTACT for SCIENTIFIC QUERIES Y.M. Cheung
- Sponsor/Initiator Erasmus Medical Center, Department of Anesthesiology, Erasmus Medical Center, Sophia Children's Hospital
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center, Department of Anesthesiology, Stichting Coolsingel, Fonds Nuts-Ohra
- PublicationsCheung 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.

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.
- Brief summaryN/A
- Main changes (audit trail)
- RECORD12-jul-2011 - 8-aug-2016


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