Lingual Ondansetron in Reduction of Spinal Hypotension in Cesarean Section

NCT07037654 | Active Not Recruiting

• 1 other identifier: Lingual ondansetron
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

spinal anesthesia; lingual ondansetron; cesarean section

Outcome Measures

Primary Outcomes (1)

• ephidrine consumption

  To evaluate the impact of lingual ondansetron on parturients having cesarean sections' overall intraoperative ephedrine consumption

  From the moment the surgery starts until it is finished, or after 90 minutes has passed, whichever is longer

Study Arms (2)

ondansetron

ACTIVE COMPARATOR

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

Drug: ondansetron lingual film

placebo

PLACEBO COMPARATOR

a placebo lingual film form will be given 15 minutes before spinal anesthesia

Drug: Placebo

Interventions

ondansetron lingual film DRUG

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

ondansetron

Placebo DRUG

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

placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: only females undergoing ceserean sections
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Faculty of Medicine, Suez Canal University

Ismailia, Egypt

Location

Study Officials

• Abdelrhman Alshawadfy

  Faculty of Medicine, Suez Canal University Ismailia, , Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of anaesthesia

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: June 25, 2025
• Study Start: June 1, 2025
• Primary Completion: December 15, 2025
• Study Completion: December 30, 2025
• Last Updated: June 25, 2025

Record last verified: 2025-06

Locations

EG (1)