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The Effect of Ondansetron on Spinal Anesthesia in Caesarean Section

NCT03931863 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2021-01-20

No results posted yet for this study

Summary

The purpose of this study is to compare the administration of two different doses of ondansetron to placebo to prevent hypotension and bradycardia following spinal anaesthesia. Apart from haemodynamic parameters (blood pressure and heart rate),characters of the spinal blockage (time of onset and regression) will be recorded too.

Conditions

Interventions

DRUG

Ondansetron 4mg

Intravenous administration of ondansetron 4mg diluted in 100ml of normal saline 0.9 percent within 10 minutes prior to spinal anesthesia.

DRUG

Ondansetron 8mg

Intravenous administration of ondansetron 8mg diluted in 100ml of normal saline 0.9 percent within 10 minutes prior to spinal anesthesia.

DRUG

100ml normal saline 0.9 percent

Intravenous administration of 100ml of normal saline 0.9 percent within 10 minutes prior to spinal anesthesia.

Sponsors & Collaborators

  • University of Athens

    collaborator OTHER

  • Aretaieion University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-22
Primary Completion
2022-05-31
Completion
2022-05-31

Countries

  • Greece

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03931863 on ClinicalTrials.gov