The Effect of Ondansetron on Cardiac Output in Elective Cesarean Deliveries

Phase 2

Completed

• Conditions: Cardiac Output
• Interventions: Drug: Ondansetron; Other: Normal saline

• Registration Number: NCT01841606
• Lead Sponsor: University of British Columbia

Brief 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.

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-11
• Study First Submitted QC: 2013-04-23
• Study First Posted: 2013-04-26
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Results First Submitted: 2017-04-27
• Status Verified: 2018-05
• Results First Submitted QC: 2018-05-08
• Last Update Submitted: 2018-05-08
• Results First Posted: 2018-05-11
• Last Update Posted: 2018-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 57

Inclusion Criteria

• Elective CD under spinal anesthesia
• Fluency in English

Exclusion Criteria

• Contraindication to spinal anesthesiA
• Allergy to ondansetron

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ondansetron	Ondansetron	4mg of IV ondansetron 5 minutes prior to initiation of spinal anesthesia
Placebo	Normal saline	10mL of IV normal saline 5 minutes prior to initiation of spinal anesthesia

Primary Outcome Measures

Name	Time	Method
Change in Cardiac Output From Baseline to 20 Minutes Post-spinal	Baseline and 20 minutes	Maximum change in cardiac output from initiation of spinal anesthesia (baseline) until uterine incision (20 minutes post-spinal)

Trial Locations

Locations (1)

BC Women's Hospital; 🇨🇦 Vancouver, British Columbia, Canada