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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
Sponsor:
Information provided by (Responsible Party):
Vit Gunka, 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.

Condition or disease Intervention/treatment Phase
Cardiac Output Drug: Ondansetron Other: Normal saline Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Experimental: Ondansetron
4mg of IV ondansetron 5 minutes prior to initiation of spinal anesthesia
Drug: Ondansetron
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




Primary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Elective CD under spinal anesthesia
  • Fluency in English

Exclusion Criteria:

  • Contraindication to spinal anesthesiA
  • Allergy to ondansetron

Information from the National Library of Medicine

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


Locations
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Canada, British Columbia
BC Women's Hospital
Vancouver, British Columbia, Canada, V6H 3N1
Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Vit Gunka, MD FRCPC University of British Columbia

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Responsible Party: Vit Gunka, Principle Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT01841606     History of Changes
Other Study ID Numbers: H12-03634
First Posted: April 26, 2013    Key Record Dates
Results First Posted: May 10, 2018
Last Update Posted: May 10, 2018
Last Verified: May 2018
Keywords provided by Vit Gunka, University of British Columbia:
Spinal anesthesia
Elective cesarean deliveries
Ondansetron
Additional relevant MeSH terms:
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Ondansetron
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Psychotropic Drugs
Anti-Anxiety Agents