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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON38275

Enrollment

225

Registered

2011-05-12

Start date

2011-07-15

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

het gaat niet over "aandoeningen" maar over pediatrische validatie van een monitoring systeem tijdens algehele anesthesie Depth of anesthesia monitoring

Interventions

None listed

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

Inclusion criteria: - Age between 1 and 18 years - Scheduled for elective surgery not requiring postoperative ventilatory support and/or sedation - Parental written informed consent (in patients older than 12 years also written informed consent from the patients

Exclusion criteria

Exclusion criteria: - Known allergy to propofol, remifentanil, or desflurane and sevoflurane - Planned postoperative admission to the Paediatric Intensive Care Unit, ventilatory support and/or sedation - Significant hearing difficulties or deafness - Acute or chronic intake of drugs affecting the EEG - Inability to obtain written informed consent

Design outcomes

Primary

Measure	Time frame
The ability of the aepEX to distinguish between different levels of vigilance/DoH in children between 1 and 18 years of age will be evaluated. Prediction probability (PK) values will be calculated to describe the relationship between the aepEX and the University of Michigan Sedation Scale (UMSS).	—

Secondary

Measure	Time frame
The dose-response relationship between different propofol-, sevoflurane- and desflurane-concentrations and the aepEX/BIS will be calculated. PK values will also be calculated for other possible indicators of DoH, such as BIS, propofol-, sevoflurane- and desflurane-concentrations and hemodynamic variables	—

Countries

Netherlands

Outcome results