Bayesian-based propofol infusion advisory tool validation

The accuracy and clinical feasibility 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.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29097

Enrollment

100

Registered

2018-02-05

Start date

2019-06-01

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

Anesthesiology, propofol infusion, target controlled infusion, medical advisory tool Anesthesiologie, propofol toediening, medisch advies systeem

Interventions

target controlled propofol infusion with and without advisory tool.

Eligibility

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 loss of consciousness (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 LOC. • 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 between 40 and 60 with or without overshoot, also called time to steady-state.	—

Measure

Time frame

• time until loss of consciousness (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 LOC. • 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 between 40 and 60 with or without overshoot, also called time to steady-state.

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Contacts

Public ContactR. Spanjersberg

Hanzeplein 1

r.spanjersberg@umcg.nl+31 (0)50 3611158

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)