Efficacy of Co-Spinal Ondansetron In Inguinal Herniorrhaphy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ondansetron 8mg, Normal Saline.
- Who it may be relevant to
- Registry conditions: Hernia, Inguinal. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Efficacy of Co-Spinal Ondansetron In Inguinal Herniorrhaphy: A Randomized Controlled Trial
Overview
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.
Interventions
- Drug Ondansetron 8mg
Patients will receive 8 mg of ondansetron (ZOFATRONE®, 8 mg/4 mL, EVA Pharma, Egypt) - Drug Normal Saline
Patients will be managed by administering 100 ml of normal saline solution as placebo
Primary outcome measures
- Ephedrine [Time frame: From the time of spinal anaesthesia administration till the end of surgery not exceeding two hors]
Secondary outcome measures (1)
- Nausea and vomiting [Time frame: From the time of end of surgery till the pass of the first 24 hours postoperatively]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Egypt · 1 center
- Suez Canal University — Ismailia
Identifiers
NCT: NCT06850740 · Co ondansetrone