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RECRUITING
NCT07357480
NA

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

Sponsor: Istanbul University - Cerrahpasa

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2026-01-14

Completion Date

2026-05

Last Updated

2026-03-25

Healthy Volunteers

No

Interventions

DEVICE

Target 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.

DEVICE

Total 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.

Locations (2)

Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine

Istanbul, Bakırköy, Turkey (Türkiye)

Cerrahpaşa Tıp Fakültesi Murat Dilmener Hastanesi

Istanbul, Istanbul, Turkey (Türkiye)