drugset / Trial / NCT03629522

Effects of Ondansetron on Hemodynamics in Cesarean Section Under Spinal Anesthesia

NCT03629522

Phase 4 Completed 100 enrolled University Hospital, Mahdia
RandomizedParallel-groupTriple-blindPrevention

Summary

BACKGROUND: Spinal anesthesia (SA) induced maternal hypotension is the most frequent and troublesome complication in cesarean section (CS), compromising both maternal and neonatal well-being. Many strategies have been used to prevent its occurrence but no single technique has been confirmed to be completely effective. the investigators hypothesized that ondansetron, a serotonin-receptor-antagonist, could have beneficial effects on maternal hemodynamics during CS under SA. METHODS: In this prospective double-blind placebo-controlled study, one hundred healthy parturients were randomized to receive either 8 mg of intravenous ondansetron (group O) or the same volume of saline (group S), 5 minutes prior to the induction of SA. All women received a coloading volume of 500 ml of saline. Maternal hemodynamics: blood pressure, heart rate and cardiac output (CO) were measured with a non-invasive device based on pulse wave transit time: the esCCO device Nihon Kohden hemodynamic monitor. Ephedrine was administered to treat hypotension (systolic blood pressure less than 80% of baseline).

Timeline

Start
2017-08-01
Primary completion
2017-11-30
Completion
2017-12-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ondansetron Other / unclassified 8 mg Intravenous

Indications

No indication recorded.