About this trial
This study aims to investigate the effect of target-controlled infusion using the Eleveld pharmacokinetic model compared with manually controlled total intravenous anesthesia on the incidence of postoperative delirium in patients undergoing supratentorial surgery. Propofol and remifentanil are administered using either target-controlled or manual infusion techniques according to the study protocol. Secondary objectives include comparisons of intraoperative anesthetic consumption, hemodynamic responses, recovery profiles, postoperative pain, and postoperative nausea and vomiting between the two anesthesia strategies. The study seeks to evaluate whether target-controlled infusion provides improved anesthetic management and postoperative outcomes compared with manual total intravenous anesthesia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients aged 18 to 60 years
Scheduled for elective supratentorial surgery under general anesthesia
American Society of Anesthesiologists (ASA) physical status I or II
Planned total intravenous anesthesia with propofol and remifentanil
Disqualifiers
Refusal or inability to provide written informed consent
American Society of Anesthesiologists (ASA) physical status III or higher
Pregnancy
Emergency surgery
Trial design
Parallel
Treatments tested in this trial
Target Controlled Infusion
DeviceTotal Intravenous Anesthesia (TIVA) will be administered using an infusion pump (e.g., BeneFusion nSP) equipped with the Eleveld pharmacokinetic model. Propofol will be initiated at a target concentration of 3-3.5 µg/ml, and Remifentanil at 2-3 ng/ml (effect-site targeting). The "opioid present" option will be selected for the propofol model. Doses will be titrated to maintain a Bispectral Index (BIS) value between 40-60 throughout the surgery.
Total Intravenous Anesthesia(TIVA)
DeviceTotal Intravenous Anesthesia (TIVA) will be administered via manual titration. Induction will be performed with 20 mg propofol boluses based on EEG changes on the BIS monitor, followed by a remifentanil infusion of 0.1 µg/kg/min. Maintenance doses will be manually adjusted by the anesthesiologist to maintain a Bispectral Index (BIS) value between 40-60 and hemodynamic stability.
Treatment groups
Trial outcomes
Primary outcomes
Incidence of Postoperative Delirium
Postoperative delirium will be assessed using the Confusion Assessment Method (CAM) during the first 72 hours after surgery
Secondary outcomes
Total Propofol and Remifentanil Consumption
The total amount of propofol and remifentanil administered intraoperatively will be recorded and compared between the study groups
Heart rate
Heart rate will be recorded as beats per minute intraoperatively and compared between groups
Blood pressure
Blood pressure will be recorded as mmHg intraoperatively and compared between groups
Burst Suppression Duration
The total duration of burst suppression observed on bispectral index monitoring during anesthesia will be recorded
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