Effects of Different Kinds, Different Doses of 5-HT3 Receptor Antagonists on Prevention of Hypotension

Study Overview
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Brief Summary
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The purpose of this study is to estimate effects of different kinds, different dose of 5-HT3 receptor antagonists on prevention of hypotension after spinal anesthesia

Official Title
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Effects of Different Kinds, Different Doses of 5-HT3 Receptor Antagonists on Prevention of Hypotension After Spinal Anesthesia

Conditions
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Hypotension, Shivering, Nausea and Vomiting, Vasopressor

Intervention / Treatment
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* Drug: ramosetron
* Drug: ondansetron
* Drug: ondansetron
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients undergoing spinal anesthesia Exclusion Criteria: hypersensitivity on 5-HT3 receptor antagonists hypertension cardiovascular disease intake of selective serotonin reuptake inhibitor

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ramosetron 0.3 mg<br>preparation of ramosetron 0.3 mg | Drug: ramosetron<br>* before 5 minutes spinal anesthesia, injection of ramosetron 0.3 mg<br>|
| Active Comparator: ondansetron 8 mg<br>preparation of ondansetron 8mg | Drug: ondansetron<br>* before 5 minutes spinal anesthesia, injection of ondansetron 8 mg<br>|
| Active Comparator: ondansetron 4 mg<br>preparation of ondansetron 4mg | Drug: ondansetron<br>* before 5 minutes spinal anesthesia, injection of ondansetron 4 mg<br>|
| Placebo Comparator: non 5-HT3 receptor antagonist<br>preparation of normal saline 5 ml | Drug: placebo<br>* before 5 minutes spinal anesthesia, injection of normal saline 5 ml<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevention of hypotension by calcaulation the gap between baseline mean arterial pressure and lowest mean arterial pressure measured during 30 minutes after spinal anesthesia. | comparasion of significantly difference in the gap between baseline mean arterial pressure and lowest mean arterial pressure measured during 30 minutes after spinal anesthesia. | up to 30mins after spinal anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevention of hypotension bycalculation the gap baseline systolic and diastolic blood pressure and lowerst systolic and diastolic blood pressure | comparasion of significantly difference in the gap between baseline systolic arterial pressure and lowest systolic arterial pressure measured during 30 minutes after spinal anesthesia and the gap between baseline diastolic arterial pressure and lowest diastolic arterial pressure measured during 30 minutes after spinal anesthesia. | up to 30mins after spinal anesthesia | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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5-HT3 receptor antagonist, hypotension, spinal anesthesia