The Effect of Ondansetron on Cardiac Output in Elective Cesarean Deliveries
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|ClinicalTrials.gov Identifier: NCT01841606|
Recruitment Status : Completed
First Posted : April 26, 2013
Results First Posted : May 10, 2018
Last Update Posted : May 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Output||Drug: Ondansetron Other: Normal saline||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||57 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Effect of Ondansetron on Cardiac Output in Elective Cesarean Deliveries Under Spinal Anesthesia: A Randomized Controlled Trial|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
4mg of IV ondansetron 5 minutes prior to initiation of spinal anesthesia
4mg of IV ondansetron
Other Name: Zofran
Placebo Comparator: Placebo
10mL of IV normal saline 5 minutes prior to initiation of spinal anesthesia
Other: Normal saline
10mL of IV normal saline
- Change in Cardiac Output From Baseline to 20 Minutes Post-spinal [ Time Frame: Baseline and 20 minutes ]Maximum change in cardiac output from initiation of spinal anesthesia (baseline) until uterine incision (20 minutes post-spinal)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01841606
|Canada, British Columbia|
|BC Women's Hospital|
|Vancouver, British Columbia, Canada, V6H 3N1|
|Principal Investigator:||Vit Gunka, MD FRCPC||University of British Columbia|