Hernia, Inguinal
Conditions
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.
Interventions
DRUGOndansetron 8mg
Patients will receive 8 mg of ondansetron (ZOFATRONE®, 8 mg/4 mL, EVA Pharma, Egypt)
DRUGNormal Saline
Patients will be managed by administering 100 ml of normal saline solution as placebo
Sponsors
Suez Canal University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ephedrine | From the time of spinal anaesthesia administration till the end of surgery not exceeding two hors | Total intraoperative ephedrine consumption. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Egypt
Outcome results
None listed