A Phase 4 interventional study of Ondansetron and Saline in Maternal Hypotension, sponsored by Cukurova University. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-22.
Sponsored by Cukurova University · Phase 4, Interventional, and Prevention
This study evaluates the effect of prophylactic ondansetron on the incidence of spinal hypotension and vasopressor consumption in caesarean section patients using norepinephrine treatment. Half of participants receive ondansetron before spinal anesthesia while the other half receive saline.
Spinal hypotension in cesarean section patients can occur vigorously and may lead to cardiovascular collapse. If doesn't treated precipitously, It can cause maternal hypotension, nausea and vomiting and fetal acidosis. Recently norepinephrine has been proposed for the prevention and treatment of spinal hypotension with less tendency to decrease HR and CO. It has been reported that ondansetron can be used for prophylaxis and treatment of nausea and vomiting, may also reduce the vasopressor requirement in patients undergoing caesarean section with spinal anesthesia. The aim of the present study is to assess the effect of prophylactic ondansetron on norepinephrine consumption and incidence of spinal hypotension, and side effects such as maternal nausea, vomiting and bradycardia.
1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.
This study's enrollment of 108 is above the median of 80 across 675 interventional studies indexed under Hypotension.
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Exclusion Criteria:
Drug: Ondansetron
Drug: Saline
After spinal anesthesia, half of the patients will be given intravenous 8 mg ondansetron.
After spinal anesthesia, half of the patients will be given intravenous 2 mlt saline.
Norepinephrine consumption
Whenever systolic arteriel pressure falls below 100 mmHg or below 20% of the preoperative baseline value in both groups norepinephrine (5 µg) will be administered intravenously and total consumption will be recorded.
Time frame: During the cesarean operation
Bradicardia
Heart rate lower than 60 beat /min will be treated with iv 0.5 mg of atropine and recorded.
Time frame: During the cesarean operation
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Cukurova University