The Effect of Ondansetron on Cardiac Output in Elective Cesarean Deliveries

Cardiac Output Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01841606
• Other study ID #: H12-03634
• Status: Completed
• Phase: Phase 2
• Start date: March 2013
• Est. completion date: December 2013

Study information

• Verified date: May 2018
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Elective CD under spinal anesthesia

• Fluency in English

Exclusion Criteria:

• Contraindication to spinal anesthesiA

• Allergy to ondansetron

Related Conditions & MeSH terms

• Cardiac Output

Intervention

Drug:
• Ondansetron
4mg of IV ondansetron

Other:
• Normal saline
10mL of IV normal saline

Locations

Country	Name	City	State
Canada	BC Women's Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Cardiac Output From Baseline to 20 Minutes Post-spinal	Maximum change in cardiac output from initiation of spinal anesthesia (baseline) until uterine incision (20 minutes post-spinal)	Baseline and 20 minutes