Actively Recruiting
Led by Istanbul University - Cerrahpasa · Updated on 2026-03-25
70
Participants Needed
2
Research Sites
N/A
Total Duration
Researchers are evaluating the effects of two anesthesia methods—target-controlled infusion using the Eleveld pharmacokinetic model and manually controlled total intravenous anesthesia—on the occurrence of postoperative delirium in patients undergoing supratentorial brain surgery. The study also compares the two approaches regarding intraoperative anesthetic use, heart rate, blood pressure, recovery process, pain after surgery, and postoperative nausea and vomiting. This prospective, randomized controlled trial includes adults aged 18 to 60 years with good physical status scheduled for elective supratentorial surgery. Participants are randomly assigned to receive either manually controlled total intravenous anesthesia, where propofol and remifentanil doses are adjusted by the anesthesiologist guided by clinical signs and brain monitoring, or target-controlled infusion, where the drugs are delivered automatically to maintain specific blood concentrations using an infusion pump with the Eleveld model. Both groups receive anesthesia induction with remifentanil, propofol, and rocuronium, followed by maintenance with propofol-remifentanil infusions. Several monitoring techniques are used throughout surgery, including bispectral index and invasive blood pressure. After surgery, patients receive pain and nausea medications, and those unable to be extubated immediately are excluded. During the study, patients undergo detailed assessments before, during, and after surgery. Delirium is evaluated using the Confusion Assessment Method at multiple time points up to three days postoperatively. Other measurements include anesthetic consumption, heart rate, blood pressure, burst suppression duration on EEG, recovery scores, pain intensity, nausea and vomiting, and overall recovery profile. Staff performing postoperative evaluations are blinded to group assignments to ensure unbiased assessments. The total participation includes preoperative evaluation, surgery, and up to 72 hours of postoperative monitoring.
CONDITIONS
Comparison of Target-Controlled and Manual Total Intravenous Anesthesia in Supratentorial Surgery
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) during routine preoperative anesthesia assessment
Duration - Surgical procedure duration (hours)
Participants undergo supratentorial surgery with total intravenous anesthesia administered either by manual titration or target-controlled infusion using the Eleveld pharmacokinetic model. Anesthetic dosing is adjusted to maintain appropriate sedation and hemodynamic stability throughout surgery.
1 intraoperative visit (in-person) including anesthesia induction, maintenance, and extubation monitoring
Duration - 3 days post-surgery
Participants are monitored for postoperative recovery including pain, nausea, vomiting, and delirium assessments for up to 3 days after surgery.
Multiple visits at 6 hours, 24, 48, and 72 hours postoperatively for delirium assessments and recovery monitoring
Total: 2 locations
1
Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine
Istanbul, Bakırköy, Turkey (Türkiye), 34153
Not Yet Recruiting
2
Cerrahpaşa Tıp Fakültesi Murat Dilmener Hastanesi
Istanbul, Istanbul, Turkey (Türkiye), 34153
Actively Recruiting
A
Ali Okuyan, MD
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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