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NOT YET RECRUITING
NCT07858149
PHASE4

Effects of Ondansetron Timing During Spinal Anesthesia for Urologic Surgery

Sponsor: Istanbul University

View on ClinicalTrials.gov

Summary

This study will evaluate whether the timing of intravenous ondansetron administration affects cerebral oxygenation and hemodynamic stability in older adults undergoing endoscopic urologic surgery under spinal anesthesia. Participants aged 65 years or older will be randomly assigned to one of three groups: ondansetron administered before spinal anesthesia, ondansetron administered after spinal anesthesia, or placebo. Ondansetron will be administered intravenously at a dose of 8 mg. Cerebral oxygenation will be assessed using bilateral frontal near-infrared spectroscopy (NIRS). Regional cerebral oxygen saturation (rSO₂) will be recorded before spinal anesthesia and at 5-minute intervals during the first 60 minutes after spinal anesthesia. The study will also evaluate blood pressure, heart rate, vasopressor requirements, bradycardia, postoperative nausea and vomiting, post-spinal headache, and postoperative delirium. The aim is to determine whether the timing of ondansetron administration influences cerebral oxygenation and hemodynamic stability after spinal anesthesia.

Official title: Clinical Effects of Ondansetron Administration in Patients Undergoing Urologic Surgery Under Spinal Anesthesia

Key Details

Gender

MALE

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

99

Start Date

2026-09-30

Completion Date

2027-01-22

Last Updated

2026-10-05

Healthy Volunteers

No

Interventions

DRUG

Ondansetron 8 mg

Ondansetron 8 mg will be administered intravenously according to the assigned study arm. In the early ondansetron arm, the drug will be administered approximately 10 minutes before completion of the intrathecal injection. In the late ondansetron arm, the drug will be administered approximately 5 minutes after completion of the intrathecal injection.

DRUG

0.9 % sodium chloride

Placebo will be administered intravenously in the same volume and appearance as the active study drug according to the blinded study protocol.

Locations (1)

Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine

Fatih, Istanbul, Turkey (Türkiye)