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Lingual Ondansetron in Reduction of Spinal Hypotension in Cesarean Section

NCT07037654 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2025-06-25

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if drug ondansetron, used in lingual form, lowers the incidence of spinal anesthesia-induced hypotension in cesarean sections. It will also learn about the safety of drug ondansetron. The main questions it aims to answer are

Does the drug ondansetron, used in lingual form, lower the incidence of spinal anesthesia-induced hypotension in cesarean sections? What medical problems do participants have when taking the drug ondansetron? Researchers will compare drug ondansetron to a placebo (a look-alike substance that contains no drug) to see if drug ondansetron works to reduce the incidence of spinal anesthesia-induced hypotension in cesarean sections

Participants will:

Take drug ondansetron or a placebo before induction of spinal anesthesia

Conditions

  • Hypotension After Spinal Anesthesia

Interventions

DRUG

ondansetron lingual film

8 mg of the lingual film form of ondansetron, given 15 minutes before spinal anesthesia

DRUG

Placebo

a placebo lingual film form, given 15 minutes before spinal anesthesia

Sponsors & Collaborators

  • Suez Canal University

    lead OTHER

Principal Investigators

  • Abdelrhman Alshawadfy · Faculty of Medicine, Suez Canal University Ismailia, , Egypt

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2025-12-15
Completion
2025-12-30

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Drugs

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 NCT07037654 on ClinicalTrials.gov