The Effect of Ondansetron on Cardiac Output in Elective Cesarean Deliveries
Information source: University of British Columbia
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cardiac Output
Intervention: Ondansetron (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: University of British Columbia Official(s) and/or principal investigator(s): Vit Gunka, MD FRCPC, Principal Investigator, Affiliation: University of British Columbia
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.
Clinical Details
Official title: The Effect of Ondansetron on Cardiac Output in Elective Cesarean Deliveries Under Spinal Anesthesia: A Randomized Controlled Trial
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Cardiac output
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.
Eligibility
Minimum age: 19 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Elective CD under spinal anesthesia
- Fluency in English
Exclusion Criteria:
- Contraindication to spinal anesthesiA
- Allergy to ondansetron
Locations and Contacts
BC Women's Hospital, Vancouver, British Columbia V6H 3N1, Canada
Additional Information
Starting date: March 2013
Last updated: December 10, 2013
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