The accuracy of a Bayesian-based, patient-individualized, pharmacodynamic advisory system to optimize propofol administration using the qCON index as a controlled variable. A comparison versus standard of care.

The accuracy of a Bayesian-based, patient-individualized, pharmacodynamic advisory system to optimize propofol administration using the qCON index as a controlled variable. A comparison versus standard of care. - BIPAS - Bayesian-based propofol infusion advisory tool validation

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50457

Enrollment

100

Registered

2019-07-16

Start date

2019-09-23

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

Anesthesiologie bij operatieduur >1 uur Narcosis sleep medication

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * 18 years or older * American Society of Anesthesiology (ASA) Classification 1-4 * Elective surgery under general anaesthesia with propofol * Surgery duration longer than one hour

Exclusion criteria

Exclusion criteria: * The use of psycho-active drugs * alcohol or recreative drug abuse.

Design outcomes

Primary

Measure	Time frame
The percentage of case time the qCON remains within +/- 10 units from targeted qCON	—

Secondary

Measure	Time frame
* time until LOC from the start of propofol infusion and the amount of propofol used during induction. * The control performance during induction will be studied taking into account the following parameters : * qCONLOC = qCON at the moment of loss of consciousness . * TqCON TARGET = observed time required for reaching the target qCON range within +/- 10 units from targeted qCON. * TPEAK, qCON = observed time required for reaching maximal drug effect (lowest qCON value). * qCONPEAK = observed qCON value at tPEAK, qCON. * TEQ = observed time required for finally reaching the target range within +/- 10 units from targeted qCON with or without overshoot, also called time to steady-state.	—

Measure

Time frame

* time until LOC from the start of propofol infusion and the amount of propofol used during induction. * The control performance during induction will be studied taking into account the following parameters : * qCONLOC = qCON at the moment of loss of consciousness . * TqCON TARGET = observed time required for reaching the target qCON range within +/- 10 units from targeted qCON. * TPEAK, qCON = observed time required for reaching maximal drug effect (lowest qCON value). * qCONPEAK = observed qCON value at tPEAK, qCON. * TEQ = observed time required for finally reaching the target range within +/- 10 units from targeted qCON with or without overshoot, also called time to steady-state.

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Countries

Netherlands

Outcome results