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COMPLETED
NCT07883772
NA

Prophylactic Ondansetron and Maternal Hemodynamics During Spinal Anesthesia for Elective Cesarean Section

Sponsor: Aydin Adnan Menderes University

View on ClinicalTrials.gov

Summary

Spinal anesthesia is the preferred technique for elective cesarean section, but it is frequently complicated by maternal hypotension and bradycardia. Activation of serotonin type 3 (5-hydroxytryptamine type 3; 5-HT3) receptors on cardiac vagal afferent nerves has been proposed as one mechanism of the Bezold-Jarisch reflex, which may contribute to sudden bradycardia and vasodilation after spinal anesthesia. Ondansetron is a selective 5-HT3 receptor antagonist. This randomized, double-blind, placebo-controlled trial evaluated whether a single intravenous (IV) dose of ondansetron 4 mg given 5 minutes before spinal anesthesia reduces maternal hypotension, bradycardia and the need for rescue medications (ephedrine and atropine) in women undergoing elective cesarean section. Hemodynamic variables and the pulse oximetry-derived perfusion index (PI) and pleth variability index (PVI) were recorded at predefined time points, including during a passive leg raising (PLR) maneuver before spinal anesthesia.

Official title: Effect of Prophylactic Intravenous Ondansetron 4 mg on Maternal Hypotension, Bradycardia and Atropine Requirement During Spinal Anesthesia for Elective Cesarean Section: a Randomized, Double-blind, Placebo-controlled Trial

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

66

Start Date

2021-04-16

Completion Date

2022-04-16

Last Updated

2026-10-23

Healthy Volunteers

No

Interventions

DRUG

Ondansetron

A single intravenous (IV) dose of ondansetron 4 milligrams (mg) in 2 milliliters (mL), administered 5 minutes before spinal anesthesia.

DRUG

Placebo (0.9% sodium chloride)

A single intravenous (IV) dose of 2 milliliters (mL) of 0.9% sodium chloride, administered 5 minutes before spinal anesthesia in a syringe identical in appearance to the active drug.

Locations (1)

Aydin Adnan Menderes University Hospital, Department of Anaesthesiology and Reanimation

Aydin, EFELER, Turkey (Türkiye)