drugset / Trial / NCT04140058

Hemodynamic Protection of Preoperative Ondansetron 15 Minutes Before Spinal Anaesthesia in Caesarean Section

NCT04140058

Phase 3 Completed 151 enrolled University of Jordan
RandomizedParallel-groupTriple-blindPrevention

Summary

Spinal anaesthesia for caesarean section is the most commonly used anaesthetic choice in caesarean deliveries. This is usually associated with maternal hypotension and other adverse side effects. Prophylactic intravenous administration of ondansetron immediately and 5 minutes preoperatively have shown to provide a protective effect against hypotension while other studies have shown little effect on the incidence of blood pressure drop in healthy parturients. The investigators will study the effect of different doses and timing of intravenous ondansetron in full term obstetric patients undergoing elective lower segment caesarean section under spinal anaesthesia on the incidence and severity of hypotension and other adverse side effects in healthy parturients having the standard intrathecal plain bupivacaine and fentanyl.

Timeline

Start
2016-01-02
Primary completion
2017-01-02
Completion
2017-01-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ondansetron Other / unclassified 4 mg Intravenous
Comparator Ondansetron Other / unclassified 6 mg Intravenous

Indications