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

NCT07357480 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-03-25

No results posted yet for this study

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.

Conditions

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

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.

Sponsors & Collaborators

  • Istanbul University - Cerrahpasa

    lead OTHER

Principal Investigators

  • Ali Okuyan, MD · İstanbul University-Cerrahpaşa, Cerrahpaşa Medical Faculty

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-14
Primary Completion
2026-05-31
Completion
2026-05-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07357480 on ClinicalTrials.gov