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Ephedrine Versus Ondansetron During Cesarean Delivery

NCT05127876 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2022-09-09

No results posted yet for this study

Summary

More than 30% of the patients receiving spinal anesthesia develop hypotension. Hypotension developed during cesarean section (C/S) under spinal anesthesia may jeopardize uteroplacental circulation leading to fetal compromise and even fetal death.

The effect of prophylactic ondansetron on blood pressure after spinal anesthesia has not been compared in a clinical trial with that of a vasoconstrictor. The investigators will compare ephedrine and ondansetron for the prevention of maternal hypotension after spinal anesthesia for elective cesarean delivery.

Conditions

  • Spinal Induced Hypotension

Interventions

DRUG

Ondansetron 4 MG

Ondansetron 4mg was given over 1 min, 5 min before spinal anesthesia

DRUG

Ondansetron 8mg

Ondansetron 8mg was given over 1 min, 5 min before spinal anesthesia

DRUG

EPHEDrine 10 Mg/mL-NaCl 0.9% Intravenous Solution

Ephedrine 10mg was given over 1 min, 5 min before spinal anesthesia

OTHER

10 mL normal saline

10 mL normal salinwe 0.9% was given over 1 min, 5 min before spinal anesthesia

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-01-10
Primary Completion
2022-03-01
Completion
2022-03-06

Countries

  • Egypt

Study Locations

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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 NCT05127876 on ClinicalTrials.gov