Target-controlled versus manually guided total intravenous anesthesia for supratentorial brain 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
This study will try a computer-driven target-controlled infusion (Eleveld model) of propofol and remifentanil instead of manual dosing during supratentorial surgery to see if it reduces postoperative delirium and improves recovery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Istanbul University - Cerrahpasa Academic / other |
| Locations | 2 sites (Istanbul, Bakırköy and 1 other locations) |
| Trial ID | NCT07357480 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized controlled trial at Istanbul University-Cerrahpaşa comparing two anesthesia strategies for elective supratentorial craniotomy: manually controlled total intravenous anesthesia (TIVA) versus target-controlled infusion (TCI) using the Eleveld pharmacokinetic model. Adult patients aged 18–60 with ASA physical status I–II who will receive propofol and remifentanil TIVA are randomized to one of the two groups. The primary outcome is the incidence of postoperative delirium, with secondary endpoints including intraoperative anesthetic consumption, hemodynamic responses, recovery profiles, postoperative pain, and postoperative nausea and vomiting. The planned sample size is 63 patients based on a priori power calculations informed by prior delirium incidence data.
Who should consider this trial
Good fit: Adults 18–60 years old with ASA I–II scheduled for elective supratentorial craniotomy who can consent and will receive propofol–remifentanil TIVA are ideal candidates.
Not a fit: Patients with ASA III or higher, emergency surgery, preoperative delirium risk factors, inability to communicate in the study setting, pregnancy, or those treated outside the study sites are unlikely to be eligible or to benefit from this protocol.
Why it matters
Potential benefit: If successful, TCI could reduce postoperative delirium and lead to smoother recovery with less pain and nausea after supratentorial surgery.
How similar studies have performed: Prior studies suggest propofol-based TIVA can lower delirium compared with inhalational anesthesia and TCI improves dosing precision, but direct evidence comparing TCI versus manual TIVA specifically for delirium is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Istanbul, Bakırköy and 1 other locations
- Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine — Istanbul, Bakırköy, Turkey (Türkiye) (Not_yet_recruiting)
- Cerrahpaşa Tıp Fakültesi Murat Dilmener Hastanesi — Istanbul, Istanbul, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Ali Okuyan, MD — İstanbul University-Cerrahpaşa, Cerrahpaşa Medical Faculty
- Study coordinator: Ali Okuyan, MD
- Email: aliokuyan@gmail.com
- Phone: +905073736874
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.