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.
Completed
- Conditions
- Anesthesiologie bij operatieduur >1 uurNarcosissleep medication
- Registration Number
- NL-OMON50457
- Lead Sponsor
- Anesthesiologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
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
* The use of psycho-active drugs
* alcohol or recreative drug abuse.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The percentage of case time the qCON remains within +/- 10 units from targeted<br /><br>qCON</p><br>
- Secondary Outcome Measures
Name Time Method <p>* time until LOC from the start of propofol infusion and the amount of propofol<br /><br>used during induction.<br /><br><br /><br>* The control performance during induction will be studied taking into account<br /><br>the following parameters :<br /><br>* qCONLOC = qCON at the moment of loss of consciousness .<br /><br>* TqCON TARGET = observed time required for reaching the target qCON range<br /><br>within +/- 10 units from targeted qCON.<br /><br>* TPEAK, qCON = observed time required for reaching maximal drug effect (lowest<br /><br>qCON value).<br /><br>* qCONPEAK = observed qCON value at tPEAK, qCON.<br /><br>* TEQ = observed time required for finally reaching the target range within +/-<br /><br>10 units from targeted qCON with or without overshoot, also called time to<br /><br>steady-state.</p><br>