aepEX™ Depth of Anaesthesia Monitoring in Children.

Evaluation of the Applicability and Reliability of the Mid-Latency Auditory Evoked Potentials derived aepEX™ as a Measure of Anaesthetic Depth in Paediatric Patients.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON27038

Enrollment

225

Registered

2011-07-12

Start date

2011-07-12

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Depth of Anaesthesia Auditory Evoked Potentials Paediatric Anaesthesia BIS monitor aepEX

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 1-18 years; 2. General anaesthesia; 3. Planned elective surgery.

Exclusion criteria

Exclusion criteria: 1. 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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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. MLAEP latencies and amplitudes will be extracted from the raw-MLAEP waveforms and linked to propofol plasma, sevoflurane and desflurane concentrations and the UMSS.	—

Contacts

Public ContactY.M. Cheung

Postbus 2060

y.m.cheung@erasmusmc.nl

Outcome results