NCT05127876

Ephedrine Versus Ondansetron During Cesarean Delivery

Ephedrine Versus Ondansetron in the Prevention of Hypotension During Cesarean Delivery: a Randomized, Double Blind, Placebo-controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 168 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

More than 30% of the patients receiving spinal anesthesia develop hypotension. Hypotension developed during cesarean section (C/S) under spinal anesthesia may jeopardize uteroplacental circulation leading to fetal compromise and even fetal death. The effect of prophylactic ondansetron on blood pressure after spinal anesthesia has not been compared in a clinical trial with that of a vasoconstrictor. The investigators will compare ephedrine and ondansetron for the prevention of maternal hypotension after spinal anesthesia for elective cesarean delivery.

Detailed description

Some vasopressive drugs including ephedrine and phenylephrine have been widely used to prevent maternal hypotension. Although ephedrine has mixed a-adrenoceptor activity , it maintains arterial pressure mainly by increases in cardiac output and heart rate as a result of its predominant activity on β1-adrenoceptors. It has been demonstrated that ondansetron preloading with crystalloid infusion reduces maternal hypotension in parturient women undergoing cesarean delivery. Ondansetron has been widely used in the clinic to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, and surgery. Ondansetron has been proven as a well-tolerated drug, but the most common side effects of ondansetron include headache, constipation, diarrhea, asthenia, and somnolence.

Conditions

• Spinal Induced Hypotension

Interventions

Type	Name	Description
DRUG	Ondansetron 4 MG	Ondansetron 4mg was given over 1 min, 5 min before spinal anesthesia
DRUG	Ondansetron 8mg	Ondansetron 8mg was given over 1 min, 5 min before spinal anesthesia
DRUG	EPHEDrine 10 Mg/mL-NaCl 0.9% Intravenous Solution	Ephedrine 10mg was given over 1 min, 5 min before spinal anesthesia
OTHER	10 mL normal saline	10 mL normal salinwe 0.9% was given over 1 min, 5 min before spinal anesthesia

Timeline

• Start date: 2022-01-10
• Primary completion: 2022-03-01
• Completion: 2022-03-06
• First posted: 2021-11-19
• Last updated: 2022-09-09

Locations

1 site across 1 country: Egypt