Bayesian optimized Propofol Target-Controlled Infusion

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23794

Enrollment

120

Registered

2014-04-16

Start date

2014-05-01

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

elective surgery under general anaesthesia with propofol and requiring an arterial line for invasive blood pressure monitoring as part of their clinical care Target-Controlled Infusion,propofol,pk/pd

Interventions

Patients receive propofol by means of a PKPD model. Initially a classical population based PKPD model is used. Based on results from intra-operative sampling an individualized PKPD model is used. Ane

Eligibility

Inclusion criteria

Inclusion criteria: -Age between : 18 years and 75 years -Informed patient consent -ASA Class (American Society of Anesthesiologists physical status) I- III - Scheduled for elective surgery under general anaesthesia with propofol and requiring an arterial line for invasive blood pressure monitoring as part of their clinical care will be enrolled.

Exclusion criteria

Exclusion criteria: •patient refusal •CNS diseases (dementia, CVI, seizures, psychiatric diseases) •Regular intake of CNS active drugs (benzodiazepines, antidepressants, antipsychotics, anticonvulsants) •Regular intake of opioids (morphine > 30 mg/day) •Relevant hepatic disease (Child B or higher) •Body mass index (BMI) 35 kg/m2 •Pregnancy, or currently nursing •Overt signs of alcohol abuse •Contraindications or allergies to the drugs used in the study •Expected blood loss during surgery > 2000 ml

Design outcomes

Primary

Measure	Time frame
We hypothesize that online adaptation or individualization of the population PKPD model of propofol will decrease the residual error between predicted and measured plasma-concentrations during maintenance of anaesthesia, when the adapted PKPD models are used to calculate propofol infusion rates required for the plasma concentrations set by the responsible anaesthetist	—

Secondary

Measure	Time frame
Secondly, we will compare the hypnotic and haemodynamic stability before and after the adaptation as measured by EEG and other vital signs clinical monitoring	—

Contacts

Public ContactR. Spanjersberg

Hanzeplein 1

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

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)