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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 uur
Narcosis
sleep 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
NameTimeMethod
<p>The percentage of case time the qCON remains within +/- 10 units from targeted<br /><br>qCON</p><br>
Secondary Outcome Measures
NameTimeMethod
<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>
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