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Recruiting NCT07357480

NCT07357480 Comparison of Target-Controlled and Manual Total Intravenous Anesthesia in Supratentorial Surgery

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Clinical Trial Summary
NCT ID NCT07357480
Status Recruiting
Phase
Sponsor Istanbul University - Cerrahpasa
Condition Postoperative Delirium (POD)
Study Type INTERVENTIONAL
Enrollment 70 participants
Start Date 2026-01-14
Primary Completion 2026-05

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age 60 Years
Study Type INTERVENTIONAL
Interventions
Target Controlled InfusionTotal Intravenous Anesthesia(TIVA)

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 70 participants in total. It began in 2026-01-14 with a primary completion date of 2026-05.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

Eligibility 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

Contact & Investigator

Central Contact

Ali Okuyan, MD

✉ aliokuyan@gmail.com

📞 +905073736874

Principal Investigator

Ali Okuyan, MD

PRINCIPAL INVESTIGATOR

İstanbul University-Cerrahpaşa, Cerrahpaşa Medical Faculty

Frequently Asked Questions

Who can join the NCT07357480 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Postoperative Delirium (POD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07357480 currently recruiting?

Yes, NCT07357480 is actively recruiting participants. Contact the research team at aliokuyan@gmail.com for enrollment information.

Where is the NCT07357480 trial being conducted?

This trial is being conducted at Istanbul, Turkey (Türkiye), Istanbul, Turkey (Türkiye).

Who is sponsoring the NCT07357480 clinical trial?

NCT07357480 is sponsored by Istanbul University - Cerrahpasa. The principal investigator is Ali Okuyan, MD at İstanbul University-Cerrahpaşa, Cerrahpaşa Medical Faculty. The trial plans to enroll 70 participants.

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