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

NCT07357480 | Recruiting

• 1 other identifier: E-24687260-604.01-1504004
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Target Controlled Infusion; Total Intravenous Anesthesia; Eleveld Model; Postoperative Delirium; Supratentorial Surgery; Bispectral Index; Propofol; Remifentanil

Outcome Measures

Primary Outcomes (1)

• Incidence of Postoperative Delirium

  Postoperative delirium will be assessed using the Confusion Assessment Method (CAM) during the first 72 hours after surgery

  Postoperative 72 hours

Secondary Outcomes (7)

• Total Propofol and Remifentanil Consumption

  Intraoperative period

• Heart rate

  Intraoperative period

• Blood pressure

  Intraoperatively

• Burst Suppression Duration

  Intraoperative period

• Recovery Profile

  From discontinuation of anesthetic infusion until 1 hour after extubation

Study Arms (2)

Manual Total Intravenous Anesthesia

EXPERIMENTAL

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.

Device: Total Intravenous Anesthesia(TIVA)

Target-Controlled Infusion (TCI)

EXPERIMENTAL

Participants receive target-controlled infusion of propofol and remifentanil using the Eleveld pharmacokinetic model, with effect-site targeting throughout the surgical procedure.

Device: Target Controlled Infusion

Interventions

Target Controlled Infusion DEVICE

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.

Target-Controlled Infusion (TCI)

Total Intravenous Anesthesia(TIVA) DEVICE

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.

Also known as: Manually controlled Total Intravenous Anesthesia

Manual Total Intravenous Anesthesia

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (2)

Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine

Istanbul, Bakırköy, 34153, Turkey (Türkiye)

NOT YET RECRUITING

Cerrahpaşa Tıp Fakültesi Murat Dilmener Hastanesi

Istanbul, Istanbul, 34153, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• Daccache N, Wu Y, Jeffries SD, Zako J, Harutyunyan R, Pelletier ED, Laferriere-Langlois P, Hemmerling TM. Safety and recovery profile of patients after inhalational anaesthesia versus target-controlled or manual total intravenous anaesthesia: a systematic review and meta-analysis of randomised controlled trials. Br J Anaesth. 2025 May;134(5):1474-1485. doi: 10.1016/j.bja.2025.02.007. Epub 2025 Mar 11.

  PMID: 40074622 BACKGROUND

• Varsha AV, Unnikrishnan KP, Saravana Babu MS, Raman SP, Koshy T. Comparison of Propofol-Based Total Intravenous Anesthesia versus Volatile Anesthesia with Sevoflurane for Postoperative Delirium in Adult Coronary Artery Bypass Grafting Surgery: A Prospective Randomized Single-Blinded Study. J Cardiothorac Vasc Anesth. 2024 Sep;38(9):1932-1940. doi: 10.1053/j.jvca.2024.05.027. Epub 2024 May 23.

  PMID: 38987101 BACKGROUND

MeSH Terms

Conditions

Emergence Delirium; Pain, Postoperative; Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Pain; Nausea; Signs and Symptoms, Digestive; Vomiting

Study Officials

• Ali Okuyan, MD

  İstanbul University-Cerrahpaşa, Cerrahpaşa Medical Faculty

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali Okuyan, MD

CONTACT

+905073736874; aliokuyan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant, Department of Anesthesiology and Reanimation

Model Details: Participants will be randomly assigned to one of two parallel groups to receive either target-controlled infusion or manually controlled total intravenous anesthesia.

Study Record Dates

• First Submitted: January 10, 2026
• First Posted: January 22, 2026
• Study Start: January 14, 2026
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)