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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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Turkey
Cerrahpaşa Tıp Fakültesi Murat Dilmener Hastanesi
RECRUITING
Istanbul
Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine
NOT_YET_RECRUITING
Istanbul
Contact Information
Primary
Ali Okuyan, MD
aliokuyan@gmail.com
+905073736874
Time Frame
Start Date: 2026-01-14
Estimated Completion Date: 2026-05
Participants
Target number of participants: 70
Treatments
Experimental: Manual Total Intravenous Anesthesia
Participants receive manually controlled total intravenous anesthesia using propofol and remifentanil, with dosing adjusted by the anesthesiologist based on clinical parameters and bispectral index monitoring.
Experimental: Target-Controlled Infusion (TCI)
Participants receive target-controlled infusion of propofol and remifentanil using the Eleveld pharmacokinetic model, with effect-site targeting throughout the surgical procedure.
Related Therapeutic Areas
Sponsors
Leads: Istanbul University - Cerrahpasa

This content was sourced from clinicaltrials.gov

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