The Effect of Ondansetron on Cardiac Output in Elective Cesarean Deliveries

NCT ID: NCT01841606

Last Updated: 2018-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2013-12-31

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.

Conditions

Cardiac Output

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Ondansetron

4mg of IV ondansetron 5 minutes prior to initiation of spinal anesthesia

Group Type: EXPERIMENTAL

Ondansetron

Intervention Type: DRUG

4mg of IV ondansetron

Placebo

10mL of IV normal saline 5 minutes prior to initiation of spinal anesthesia

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: OTHER

10mL of IV normal saline

Interventions

Ondansetron

4mg of IV ondansetron

Intervention Type: DRUG

Normal saline

10mL of IV normal saline

Intervention Type: OTHER

Other Intervention Names

Zofran

Eligibility Criteria

Inclusion Criteria

• Elective CD under spinal anesthesia
• Fluency in English

Exclusion Criteria

• Contraindication to spinal anesthesiA
• Allergy to ondansetron

• Minimum Eligible Age: 19 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Vit Gunka

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vit Gunka, MD FRCPC

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

BC Women's Hospital

Vancouver, British Columbia, Canada

Countries

Canada

Other Identifiers

H12-03634

Identifier Type: -

Identifier Source: org_study_id