RecruitingNot ApplicableNCT07357480

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

Comparison of Target-Controlled Infusion Using the Eleveld Model and Manual Total Intravenous Anesthesia on Intraoperative Anesthetic Consumption and Postoperative Pain and Delirium in Supratentorial Surgery

Sponsor

Istanbul University - Cerrahpasa

Enrollment

70 participants

Start Date

Jan 14, 2026

Study Type

INTERVENTIONAL

Conditions

Postoperative Pain Postoperative Delirium (POD)Burst Suppression PONV Recovery Period, Anesthesia

Summary

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

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Target Controlled Infusion and a medical device called Total Intravenous Anesthesia(TIVA) for people with burst suppression, ponv, and other related conditions. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years to 60 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETarget Controlled Infusion

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.

DEVICETotal Intravenous Anesthesia(TIVA)

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.