Efficacy of Co-Spinal Ondansetron In Inguinal Herniorrhaphy

NCT06850740 | Enrolling By Invitation

• 1 other identifier: Co ondansetrone
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Hernia, Inguinal

Outcome Measures

Primary Outcomes (1)

• Ephedrine

  Total intraoperative ephedrine consumption.

  From the time of spinal anaesthesia administration till the end of surgery not exceeding two hors

Secondary Outcomes (1)

• Nausea and vomiting

  From the time of end of surgery till the pass of the first 24 hours postoperatively

Study Arms (2)

Ondansetrone

ACTIVE COMPARATOR

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

Saline

PLACEBO COMPARATOR

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

Interventions

Ondansetron 8mg DRUG

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

Also known as: OND

Ondansetrone

Normal Saline DRUG

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

Also known as: Saline

Saline

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Suez Canal University

Ismailia, 41511, Egypt

Location

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

Ondansetron; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

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: assistant professor

Study Record Dates

• First Submitted: February 22, 2025
• First Posted: February 27, 2025
• Study Start: March 15, 2025
• Primary Completion: June 15, 2025
• Study Completion: August 15, 2025
• Last Updated: April 30, 2025

Record last verified: 2025-04

Locations

EG (1)