Efficacy of Co-Spinal Ondansetron In Inguinal Herniorrhaphy

NCT ID: NCT06850740

Last Updated: 2025-04-30

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-15
• Study Completion Date: 2025-08-15

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.

Conditions

Hernia, Inguinal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Ondansetron 8mg

Intervention Type: DRUG

Patients will receive 8 mg of ondansetron (ZOFATRONE®, 8 mg/4 mL, EVA Pharma, Egypt)

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.

Group Type: PLACEBO_COMPARATOR

Normal Saline

Intervention Type: DRUG

Patients will be managed by administering 100 ml of normal saline solution as placebo

Interventions

Ondansetron 8mg

Patients will receive 8 mg of ondansetron (ZOFATRONE®, 8 mg/4 mL, EVA Pharma, Egypt)

Intervention Type: DRUG

Normal Saline

Patients will be managed by administering 100 ml of normal saline solution as placebo

Intervention Type: DRUG

Other Intervention Names

OND; Saline

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suez Canal University

OTHER

Sponsor Role: lead

Responsible Party

Abdelrhman Alshawadfy

assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Suez Canal University

Ismailia, , Egypt

Countries

Egypt

Other Identifiers

Co ondansetrone

Identifier Type: -

Identifier Source: org_study_id