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COMPLETED
NCT07886151
PHASE4

Prophylactic Ondansetron for Preventing Spinal Anesthesia-Induced Hypotension in Elective Cesarean Section

Sponsor: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

View on ClinicalTrials.gov

Summary

Spinal anesthesia is the preferred technique for elective cesarean section, but it frequently causes maternal hypotension due to sympathetic blockade and the Bezold-Jarisch reflex, which can threaten both mother and baby. Ondansetron, a serotonin 5-HT3 receptor antagonist commonly used to prevent nausea and vomiting, may attenuate this reflex. The purpose of this prospective, randomized, controlled, single-blind study is to evaluate whether a single prophylactic intravenous dose of ondansetron (4 mg) given before spinal anesthesia reduces the incidence of hypotension in women undergoing elective cesarean section. Vasopressor (ephedrine) requirement, heart rate, postspinal shivering, intraoperative nausea and vomiting, and newborn Apgar scores are also compared between the ondansetron and control (saline) groups.

Official title: Efficacy of Prophylactic Ondansetron in Preventing Hypotension After Spinal Anesthesia in Elective Cesarean Sections: A Prospective Randomized Controlled Trial

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

96

Start Date

2026-02-02

Completion Date

2026-07-10

Last Updated

2026-10-21

Healthy Volunteers

No

Interventions

DRUG

Ondansetron

A single dose of 4 mg ondansetron diluted in 100 mL of 0.9% sodium chloride warmed to 37°C, administered as an intravenous infusion starting 10 minutes before spinal anesthesia.

DRUG

Placebo (0.9% Sodium Chloride)

100 mL of 0.9% sodium chloride warmed to 37°C, identical in appearance to the study solution, administered as an intravenous infusion starting 10 minutes before spinal anesthesia.

Locations (1)

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Diyarbakır, Turkey (Türkiye)