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Active, not recruiting Not applicable

Lingual Ondansetron in Reduction of Spinal Hypotension in Cesarean Section

NCT07037654 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2025-06-01
Last updated
2026-05-27

Condition(s) studied

Hypotension After Spinal Anesthesia

Investigational drug(s) / intervention(s)

ondansetron lingual filmPlacebo

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

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

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

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
40 Years
Healthy volunteers
No
Inclusion Criteria: * Age: 18- 40 years old parturients. * Height: 150 to 180 cm * Patients are ASA II (American Society of Anesthesiologists physical status grade II) = (pregnant and patients with mild systemic disease and no functional limitations). * Patients scheduled for elective cesarean section in Suez Canal University Hospitals. Exclusion Criteria: * Patients' refused to participate in the study. * Contraindications of spinal anesthesia (patients with marked deformities or infections at the site of spinal injection, and coagulopathy). * Known allergy to bupivacaine or ondansetron.

Primary outcome measure(s)

  • ephidrine consumption — From the moment the surgery starts until it is finished, or after 90 minutes has passed, whichever is longer
    To evaluate the impact of lingual ondansetron on parturients having cesarean sections' overall intraoperative ephedrine consumption

Trial sites (1)

FacilityCityRegionStatus
Faculty of Medicine, Suez Canal University Ismailia Egypt
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07037654 on ClinicalTrials.gov ↗ ← All trials in Egypt