Ain Shams University Hospitals
Cairo, Egypt
NCT Number: NCT05127876
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.
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Notify Me18 year–40 year
Female
Interventional
Phase 4
Cairo, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ondansetron 4mg was given over 1 min, 5 min before spinal anesthesia
Other names: Low dose ondansetron group
Ondansetron 8mg was given over 1 min, 5 min before spinal anesthesia
Other names: Higher dose Ondanseteron group
Ephedrine 10mg was given over 1 min, 5 min before spinal anesthesia
Other names: Ephedrine group
10 mL normal salinwe 0.9% was given over 1 min, 5 min before spinal anesthesia
Other names: Placebo group
Time frame: 45 minutes
Mean arterial blood pressure was recorded every 2 minute for 10 minutes then every 5 minutes until delivery. Time of intrathecal injection was considered as 0 min.
Time frame: 5 min after fetal delivery
1and 5 min after fetal delivery
Ain Shams University
Other
Ephedrine Versus Ondansetron in the Prevention of Hypotension During Cesarean Delivery: a Randomized, Double Blind, Placebo-controlled Trial
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