Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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23 March 2015 |
Main ID: |
NCT02194192 |
Date of registration:
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16/07/2014 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Prophylaxis Ephedrine or Ondansetron Prevents Hypotension After Spinal Anesthesia for Cesarean Section
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Scientific title:
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Prophylaxis Ephedrine or Ondansetron Prevents Hypotension After Spinal Anesthesia for Cesarean Section; a Randomized, Double Blinded, Placebo Controlled Trial |
Date of first enrolment:
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July 2014 |
Target sample size:
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168 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT02194192 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
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Phase:
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N/A
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Countries of recruitment
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Thailand
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Contacts
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Name:
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Patchareya Nivatpumin, M.D. |
Address:
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Telephone:
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Email:
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Affiliation:
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Department of Anesthesiology, Faculty of Medicine Siriraj Hospital |
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Anesthesia; Adverse Effect, Spinal and Epidural
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Intervention(s)
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Drug: Ephedrine
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Drug: Placebo
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Drug: Ondansetron
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Primary Outcome(s)
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Comparing efficacy of ondansetron to ephedrine in the prevention of hypotension.
[Time Frame: After spinal block to until baby delivered]
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Secondary Outcome(s)
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Maternal symptom: Nausea and vomiting after spinal anesthesia
[Time Frame: After spinal anesthesia until baby delivered]
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Secondary ID(s)
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(IO)R015731034
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810/2556(EC2)
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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