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

Inclusion Criteria5

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
Ability to provide written informed consent

Exclusion Criteria10

Refusal or inability to provide written informed consent
American Society of Anesthesiologists (ASA) physical status III or higher
Pregnancy
Emergency surgery
Presence of brain herniation
Anticipated or documented difficult airway
Inability to communicate effectively (e.g., non-Turkish speaking or hearing impairment)
Preoperative risk factors for delirium, including substance abuse, use of neuropsychiatric medications, preoperative hemoglobin level \< 8 g/dL, malnutrition, or electrolyte or thyroid hormone abnormalities
Intraoperative deviation from the study protocol, including changes in surgical or anesthetic technique or occurrence of major intraoperative complications
Contraindications to propofol or remifentanil

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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.