Bayesian optimized Propofol Target-Controlled Infusio

Conditions: Patients requiring general anaesthesia for surgery using propofol and requiring an arterial line for invasive blood pressure monitoring as part of their clinical care.
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2013-003909-26-NL

Lead Sponsor: MCG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 195
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 195

Exclusion Criteria

potential subject who meets any of the following criteria will be excluded from participation in this study:

•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) <18 or >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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: We hypothesize that online adaptation or tuning 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 target concentrations set by the responsible anaesthetist. ;Secondary Objective: Secondly, we will compare the hypnotic and haemodynamic stability before and after the adaptation as measured by EEG and other vital signs clinical monitoring (heart rate, blood pressure). ;Primary end point(s): The main study parameter is the ratio between measured and predicted propofol concentration, defined as the median absolute prediction error (see statistical section);Timepoint(s) of evaluation of this end point: 2 years after last inclusion

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The hypnotic and haemodynamic stability pre- and post- adaptation as measured by EEG and other vital signs clinical monitoring (heart rate, blood pressure).;Timepoint(s) of evaluation of this end point: 2 years after last inclusion