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Lingual Ondansetron in Reduction of Spinal Hypotension in Cesarean Section

Efficacy of Lingual Ondansetron in Reduction of Spinal Anesthesia-induced Hypotension In Cesarean Section; a Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07037654
Enrollment
112
Registered
2025-06-25
Start date
2025-06-01
Completion date
2026-09-01
Last updated
2026-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypotension After Spinal Anesthesia

Keywords

spinal anesthesia, lingual ondansetron, cesarean section

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

Detailed description

Spinal anesthesia, which is extensively used in a variety of surgical operations, frequently causes hypotension due to sympathetic nerve blocking. This reduction in blood pressure might have negative consequences, especially in people with cardiovascular comorbidities. Ondansetron, a selective serotonin 5-HT3 receptor antagonist, is well known for its antiemetic effects. However, its ability to reduce hypotension during spinal anesthesia has sparked great interest in recent years. Thus, it regulates cardiovascular function, vasodilation, and vascular tone and helps to maintain a more steady hemodynamic profile during spinal anesthesia. A growing amount of evidence supports the use of ondansetron as a preventive strategy against spinal anesthesia-induced hypotension. This technique not only improves patient safety but also minimizes intraoperative problems. As research advances, using ondansetron in anesthetic protocols may become commonplace, reflecting its numerous benefits in the perioperative situation. Objective: To investigate the efficacy of the lingual film form of ondansetron after use in parturients undergoing spinal anesthesia during cesarean delivery to reduce total ephedrine consumption and spinal-induced hypotension. Methodology: Following the administrative ethical committee approval and informed patient consent obtained from 112 patients undergoing cesarean delivery in Suez Canal University Hospital, they will be randomly assigned to one of the two groups using a computer software program. Group A (56 patients) will be administered 8 mg of the lingual film form of ondansetron, given 15 minutes before spinal anesthesia. Group B (56 patients) will be administered a placebo lingual film form 15 minutes before spinal anesthesia. Expected outcome: The investigators can expect a reduction in the total ephedrine consumption and more cardiovascular stability based on the previous trial.

Interventions

DRUGondansetron lingual film

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

DRUGPlacebo

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

Sponsors

Suez Canal University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 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.

Design outcomes

Primary

MeasureTime frameDescription
ephidrine consumptionFrom the moment the surgery starts until it is finished, or after 90 minutes has passed, whichever is longerTo evaluate the impact of lingual ondansetron on parturients having cesarean sections' overall intraoperative ephedrine consumption

Countries

Egypt

Contacts

PRINCIPAL_INVESTIGATORAbdelrhman Alshawadfy

Faculty of Medicine, Suez Canal University Ismailia, , Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 28, 2026