Prophylaxis Ephedrine or Ondansetron Prevents Hypotension After Spinal Anesthesia for Cesarean Section

Study Overview
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Brief Summary
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Maternal hypotension after spinal anesthesia in parturients undergoing cesarean section is a very common problem leading to several complications to both patients and their babies. It can cause maternal discomfort, lightheadedness, nausea and vomiting. The most important complication is the decreasing blood flow to babies; which may lead to fetal acidosis. Many interventions has been studied in order to prevent hypotension after spinal anesthesia in cesarean section e.g., fluid loading: colloid vs crystalloid, medications: ephedrine, phenylephrine, and metaraminol, etc. The recent study showed ondansetron (the antiemetic drug) can be effectively used to prevent hypotension after spinal anesthesia in normal patients or parturients. The action of ondansetron is believed to inhibit Bezold-Jarish reflex. This aim of this study is to compare the efficacy of ephedrine and ondansetron in the prevention of maternal hypotension after spinal anesthesia in cesarean section.

Official Title
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Prophylaxis Ephedrine or Ondansetron Prevents Hypotension After Spinal Anesthesia for Cesarean Section; a Randomized, Double Blinded, Placebo Controlled Trial

Conditions
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Anesthesia; Adverse Effect, Spinal and Epidural

Intervention / Treatment
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* Drug: Placebo
* Drug: Ondansetron
* Drug: Ephedrine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years Elective cesarean section Patient accept spinal anesthesia ASA classification I-II Term, Singleton pregnancy Understand all process in this study Exclusion Criteria: DM any type that not the gestational DM Hypertensive disorder BMI>40 Complicated pregnancy such as placenta previa, preeclampsia Allergic to study drugs Long QT syndrome Contraindication to spinal anesthesia

Ages Eligible for Study
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Minimum Age: 18 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: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group E<br>Ephedrine 10 mg in Normal Saline 10 ml | Drug: Ephedrine<br>* Ephedrine 10 mg IV after spinal anesthesia<br>|
| Active Comparator: Group O<br>Ondansetron 8 mg in Normal saline 10 ml | Drug: Ondansetron<br>* Ondasetron 8 mg IV after spinal anesthesia<br>|
| Placebo Comparator: Group P<br>Normal saline 10 ml | Drug: Placebo<br>* Normal saline 10 ml<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparing efficacy of ondansetron to ephedrine in the prevention of hypotension. | Ondansetron or ephedrine will be given immediately after spinal anesthesia, then record blood pressure and heart rate one-minutely until delivery. | After spinal block to until baby delivered | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal symptom: Nausea and vomiting after spinal anesthesia |  | After spinal anesthesia until baby delivered | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prevention of hypotension, spinal anesthesia, cesarean section, ephedrine, ondansetron