Bayesian optimized Propofol Target-Controlled Infusio

Phase 4

Completed

Conditions: aandoeningen waarbij een chirurgische behandeling onder narcose is vereist.
propofol
Target-Controlled Infusion

Registration Number: NL-OMON40537

Lead Sponsor: anesthesiologie- onderzoeksbureau

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 120

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

• 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: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the ratio between measured and predicted propofol<br /><br>concentratie, defined as the median absolute prediction error.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The hypnotic and haemodynamic stability pre- and post adaptation as measured by<br /><br>EEG (BIS) and other vital signs clinical monitoring (heart rate, blood<br /><br>pressure, venous oxygen saturation, capnography).</p><br>