Norepinephrine Consumption After Prophylactic Ondansetron

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Does Prophylactic Ondansetron Reduce Norepinephrine Consumption in Patients Undergoing Caesarean Section With Spinal Anesthesia?

Conditions
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Maternal Hypotension

Intervention / Treatment
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* Drug: Ondansetron
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA physical status I-II patients Between the ages of 18 and 40 years Scheduled for elective caesarean section with spinal anesthesia Exclusion Criteria: History of hypertension History of severe hepato-renal disease, sensitivity or contraindication to ondansetron, Drug or alcohol abuse Contraindication to regional anesthesia.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ondansetron<br> | Drug: Ondansetron<br>* After spinal anesthesia, half of the patients will be given intravenous 8 mg ondansetron.<br>|
| Active Comparator: Saline<br> | Drug: Saline<br>* After spinal anesthesia, half of the patients will be given intravenous 2 mlt saline.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | During the cesarean operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bradicardia | Heart rate lower than 60 beat /min will be treated with iv 0.5 mg of atropine and recorded. | During the cesarean operation |