NCT02883192

Brief Summary

Cesarean section is a frequent procedure in the obstetric surgery. The most widely used anesthesia technique for cesarean delivery is the spinal anesthesia The incidence of spinal anesthesia induced hypotension and bradycardia is high as 60% in the obstetric population. The aim of the study is to investigate the effect of the preventive use of Ondansetron on the prevention of hypotension

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 30, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

August 31, 2016

Status Verified

August 1, 2016

Enrollment Period

8 months

First QC Date

August 25, 2016

Last Update Submit

August 30, 2016

Conditions

Adverse Anesthesia Outcome

Keywords

Cesarean sectionspinal anesthesiahypotensionondansetron

Outcome Measures

Primary Outcomes (1)

  • Blood pressure measure in mmHg.

    40 minutes

Secondary Outcomes (1)

  • Vomiting measure in number scale

    40 minutes

Study Arms (2)

ondansetron

EXPERIMENTAL

ondansetron

Drug: Ondansetron

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

OndansetronDRUG

Zofran 4 mg.

Also known as: Zofran
ondansetron
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • American Society of Anesthesia (ASA) physical status I or II

You may not qualify if:

  • Preeclampsia Cardiovascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Luis A Gaitini M.D.

Haifa, Israel

RECRUITING

MeSH Terms

Conditions

Hypotension

Interventions

Ondansetron

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-Ring

Study Officials

  • mira koch, M.A.

    Bnai Zion Medical Center

    STUDY CHAIR

Central Study Contacts

Luis A Gaitini, M.D.

CONTACT

# 972 4 8359346luis.gaitini@b-zion.org.il

Mostafa Somri, M.D.

CONTACT

# 972 4 8359304mostafa.somri@b-zion.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

August 25, 2016

First Posted

August 30, 2016

Study Start

February 1, 2016

Primary Completion

October 1, 2016

Study Completion

December 1, 2016

Last Updated

August 31, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will share

Locations

IL(1)