NCT01841606

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 26, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
4.4 years until next milestone

Results Posted

Study results publicly available

May 11, 2018

Completed
Last Updated

May 11, 2018

Status Verified

May 1, 2018

Enrollment Period

9 months

First QC Date

March 11, 2013

Results QC Date

April 27, 2017

Last Update Submit

May 8, 2018

Conditions

Cardiac Output

Keywords

Spinal anesthesiaElective cesarean deliveriesOndansetron

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Ondansetron

EXPERIMENTAL

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

Drug: Ondansetron

Placebo

PLACEBO COMPARATOR

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

Other: Normal saline

Interventions

OndansetronDRUG

4mg of IV ondansetron

Also known as: Zofran
Ondansetron
Normal salineOTHER

10mL of IV normal saline

Placebo

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective CD under spinal anesthesia
  • Fluency in English

You may not qualify if:

  • Contraindication to spinal anesthesiA
  • Allergy to ondansetron

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BC Women's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

Location

MeSH Terms

Interventions

OndansetronSaline Solution

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-RingCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Results Point of Contact

Title
Mr. James Taylor
Organization
UBC Department of Anesthesia - BC Women's Hospital
james.taylor1@phsa.ca
604-875-2424

Study Officials

  • Vit Gunka, MD FRCPC

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

March 11, 2013

First Posted

April 26, 2013

Study Start

March 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

May 11, 2018

Results First Posted

May 11, 2018

Record last verified: 2018-05

Locations

CA(1)