Comparison of the efficacy of prophylactic ondansetron and ephedrine on hypotension associated with spinal anesthesia in cesarean section

Comparison of the efficacy of prophylactic ondansetron and ephedrine on hypotension associated with spinal anesthesia in cesarean section

The clinical trial has a control group, with parallel groups, double-blind, approved, phase 2-3 in 180 patients. Randomization is by using https://www.sealedenvelope.com website.

Intervention group one: patients will receive Ephedrine 10 mg , during 5 minutes before spinal anesthesia .Intervention group two: patients will receive Ondansetron 8 mg , during 5 minutes before spinal anesthesia. Control group: patients will receive10 cc normal saline as placebo during 5 minutes before spinal anesthesia. Anesthesiologist and surgeon were blinded, Neither the participants nor the investigators involved in data collection and assessing the outcomes are aware of the identity of the target drugs.

Inclusion Criteria: Age 18 years, Elective cesarean section, ASA classification I-II, Term and singleton pregnancy. Exclusion Criteria: Diabetes, Hypertension , Body mass index 40, Complicated pregnancy such as placenta Previa, preeclampsia, history of Long QT syndrome, history of Electrolyte imbalance, Contraindication to the spinal anesthesia, Failed spinal block or total spinal converted to general anesthesia, history of allergy to or side effects to the study drugs.

Intervention group one: patients will receive Ephedrine 10 mg , during 5 minutes before spinal anesthesia . Intervention group two: patients will receive Ondansetron 8 mg , during 5 minutes before spinal anesthesia. Control group: patients will receive10 cc normal saline as placebo during 5 minutes before spinal anesthesia.

Hemodynamic changes ,nausea and vomiting, motor block duration .

Patients are randomly divided into three groups of drugs and placebo. Randomization is by using https://www.sealedenvelope.com website.

Medications were prepared by an anesthesia nurse who were totally unaware of the nature of the study who is verified the allocation and prepared ondansetron 8 mg with 0.9% saline solution to a total volume of 10 mL or a placebo of 0.9% saline solution 10 mL and ephedrine 10 mg with 0.9% saline solution to a total volume of 10 ml. While anesthesiologist and surgeon were blinded, Neither the participants nor the investigators involved in data collection and assessing the outcomes are aware of the identity of the target drugs. The syringes had no identifying markers indicating group allocation. The nurse injected the contents of the 10-mL syringe intravenously over 60 s, 5 min before the lumbar puncture. The anesthetist is blinded to group allocation.

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