Comparison of Target-Controlled and Manual Total Intravenous Anesthesia in Supratentorial Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorIstanbul University - Cerrahpasa

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Target Controlled Infusion

    Device

    Total 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)

    Device

    Total 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

70 Participants
are divided into 2 treatment groups
Group A: Manual Total Intravenous AnesthesiaExperimental treatment 1 intervention
Group B: Target-Controlled Infusion (TCI)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Postoperative Delirium

Postoperative delirium will be assessed using the Confusion Assessment Method (CAM) during the first 72 hours after surgery

Time frame
Postoperative 72 hours

Secondary outcomes

1

Total Propofol and Remifentanil Consumption

The total amount of propofol and remifentanil administered intraoperatively will be recorded and compared between the study groups

Time frame
Intraoperative period
2

Heart rate

Heart rate will be recorded as beats per minute intraoperatively and compared between groups

Time frame
Intraoperative period
3

Blood pressure

Blood pressure will be recorded as mmHg intraoperatively and compared between groups

Time frame
Intraoperatively
4

Burst Suppression Duration

The total duration of burst suppression observed on bispectral index monitoring during anesthesia will be recorded

Time frame
Intraoperative period

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.