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Enrolling by Invitation

NCT Number: NCT06850740

Efficacy of Co-Spinal Ondansetron In Inguinal Herniorrhaphy

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.

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Suez Canal University

Ismailia, 41511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ondansetron 8mg

Drug

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

Other names: OND

normal saline

Drug

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

Other names: Saline

Primary outcomes

  1. Ephedrine

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

    Total intraoperative ephedrine consumption.

Secondary outcomes

  1. Nausea and vomiting

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

    Incidence of post operative nausea and vomiting.

Sponsors and collaborators

Lead sponsor

Suez Canal University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 27, 2025
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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