Efficacy of Co-Spinal Ondansetron In Inguinal Herniorrhaphy

The Efficacy of Co-Spinal Ondansetron In Inguinal Herniorrhaphy: A Randomized Controlled Trial

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 recently sparked great interest. In clinical practice, administering ondansetron before spinal anesthesia has produced promising results.

Study Overview

• Status: Enrolling by invitation
• Conditions: Hernia, Inguinal
• Intervention / Treatment: Drug: Ondansetron 8mg; Drug: Normal Saline

Detailed Description

This prospective randomized double-blinded controlled study will be conducted on 46 patients undergoing inguinal herniorrhaphy at Suez Canal University Hospital and will be randomly assigned to one of the two groups using a table of random numbers. Group A (23 patients) will be administered 8 mg of ondansetron diluted in 100 ml of normal saline, starting with the skin preparation for spinal anesthesia through the intravenous axis to be finished in 10 minutes. Group B (23 patients) will be administered 100 ml of normal saline, starting with the skin preparation for spinal anesthesia through the intravenous axis, to be finished in 10 minutes.

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Ismailia, Egypt, 41511
    • Suez Canal University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients scheduled for inguinal herniorrhaphy in Suez Canal University Hospitals
• Height: 150 to 180 cm.
• Body mass index (BMI): not more than 35 kg/m².
• Patients are ASA I (American Society of Anesthesiology physical status Grade I) = (normal healthy patients), ASA II (American Society of Anesthesiologists physical status Grade II) = (patients with mild systemic disease and no functional limitations).

Exclusion Criteria:

• Patients refused to participate in the study.
• Contraindications of spinal anesthesia.
• Known allergy to bupivacaine or ondansetron.
• Patients with a history of arrhythmia, especially those with prolonged QT intervals.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ondansetrone; will receive 8 mg of ondansetron (ZOFATRONE®, 8 mg/4 mL, EVA Pharma, Egypt) over 100 ml of normal saline solution over 10 minutes, starting with skin preparation for spinal anesthesia via the intravenous axis and a rapid intravenous (IV) infusion of 15 mL/kg of Ringer's solution that will be co-loaded during spinal anesthesia.	Drug: Ondansetron 8mg; Patients will receive 8 mg of ondansetron (ZOFATRONE®, 8 mg/4 mL, EVA Pharma, Egypt); Other Names: OND
Placebo Comparator: Saline; will be managed by administering 100 ml of normal saline solution over 10 minutes, starting with the skin preparation for spinal anesthesia via the intravenous axis and a rapid intravenous (IV) infusion of 15 mL/kg of Ringer's solution that will be co-loaded during spinal anesthesia.	Drug: Normal Saline; Patients will be managed by administering 100 ml of normal saline solution as placebo; Other Names: Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ephedrine	Total intraoperative ephedrine consumption.	From the time of spinal anaesthesia administration till the end of surgery not exceeding two hors

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nausea and vomiting	Incidence of post operative nausea and vomiting.	From the time of end of surgery till the pass of the first 24 hours postoperatively

Collaborators and Investigators

• Sponsor: Suez Canal University

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2025
• Primary Completion (Estimated): June 15, 2025
• Study Completion (Estimated): August 15, 2025

Study Registration Dates

• First Submitted: February 22, 2025
• First Submitted That Met QC Criteria: February 22, 2025
• First Posted (Actual): February 27, 2025

Study Record Updates

• Last Update Posted (Actual): April 30, 2025
• Last Update Submitted That Met QC Criteria: April 26, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia; Hernia, Abdominal; Hernia, Inguinal; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Dermatologic Agents; Neurotransmitter Agents; Antipruritics; Serotonin 5-HT3 Receptor Antagonists; Serotonin Antagonists; Serotonin Agents; Ondansetron
• Other Study ID Numbers: Co ondansetrone

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No