Efficacy of Co-Spinal Ondansetron In Inguinal Herniorrhaphy

Not Applicable

• Conditions: Hernia, Inguinal
• Interventions: Drug: Ondansetron 8mg; Drug: Normal Saline

• Registration Number: NCT06850740
• Lead Sponsor: Suez Canal University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2025-02-22
• Study First Submitted QC: 2025-02-22
• Study First Posted: 2025-02-27
• Study Start: 2025-03-15
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-26
• Last Update Posted: 2025-04-30
• Primary Completion: 2025-06-15
• Study Completion: 2025-08-15

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ondansetrone	Ondansetron 8mg	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.
Saline	Normal 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.

Primary Outcome Measures

Name	Time	Method
Ephedrine	From the time of spinal anaesthesia administration till the end of surgery not exceeding two hors	Total intraoperative ephedrine consumption.

Secondary Outcome Measures

Name	Time	Method
Nausea and vomiting	From the time of end of surgery till the pass of the first 24 hours postoperatively	Incidence of post operative nausea and vomiting.

Trial Locations

Locations (1)

Suez Canal University; 🇪🇬 Ismailia, Egypt