NCT01841606

The Effect of Ondansetron on Cardiac Output in Elective Cesarean Deliveries

The Effect of Ondansetron on Cardiac Output in Elective Cesarean Deliveries Under Spinal Anesthesia: A Randomized Controlled Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: University of British Columbia · Academic / Other
• Sex: Female
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

Ondansetron is a medication routinely given to mothers having cesarean deliveries to help prevent and treat nausea and vomiting. The investigators are studying the hemodynamic effects of prophylactic ondansetron on parturients undergoing elective cesarean deliveries under spinal anesthesia.

Detailed description

Spinal anesthesia is a routine anesthetic technique for elective cesarean deliveries. Although this provides safe and effective surgical anesthesia, it is not without side effects, including both hypotension and bradycardia. The incidence of hypotension following spinal anesthesia has been estimated to be as high as 80% in an obstetric population. A number of factors are also likely involved in the development of hypotension and bradycardia, including the Bezold-Jarisch Reflex (BJR). Two human studies with spinal anesthesia, one in an obstetric population, have demonstrated ondansetron's ability to presumably attenuate the BJR and better prevent hypotension by antagonism of 5-HT3 receptors. Maintenance of blood pressure and heart rate are vitally important, as they are required for adequate perfusion of the fetus prior to delivery. The investigators plan to investigate the hemodynamic effects of prophylactic ondansetron on parturients undergoing elective cesarean deliveries under spinal anesthesia. Ondansetron is classified as a Pregnancy Category B drug by the FDA, meaning that no adverse fetal effects have been demonstrated in animal studies, but that there is a lack of well controlled studies in pregnant humans.

Conditions

• Cardiac Output

Interventions

Type	Name	Description
DRUG	Ondansetron	4mg of IV ondansetron
OTHER	Normal saline	10mL of IV normal saline

Timeline

• Start date: 2013-03-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2013-04-26
• Last updated: 2018-05-11
• Results posted: 2018-05-11

Locations

1 site across 1 country: Canada