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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02468323 |
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Date of registration:
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07/06/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Prophylactic Antiemetic Efficacy of Palonosetron Versus Ondansetron for Cesarean Sections Under Regional Anesthesia
PONV |
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Scientific title:
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Prophylactic Antiemetic Efficacy of Palonosetron Versus Ondansetron for Cesarean Sections Under Regional Anesthesia: Study Single Center, Prospective, Double-blind, Randomized, Placebo Controlled |
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Date of first enrolment:
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October 2015 |
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Target sample size:
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150 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02468323 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Fabricio T Mendonca, MD, TSA |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital de Base do Distrito Federal |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- American Society of Anesthesiologists class I or II
- Scheduled for cesarean section on Maternal and Child Hospital of Brasilia, Federal
District, Brazil
Exclusion Criteria:
- patients who had received antiemetics, diabetic, allergic to any study drug,
corticosteroid use, psychoactive drugs, patients with vomiting in the course of
gastrointestinal disease, eclampsia, heart disease, smokers, any evidence of fetal
distress, psychiatric disease or who refused to participate.
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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PONV
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Intervention(s)
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Drug: Palonosetron
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Drug: Placebo
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Drug: Ondansetron
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Primary Outcome(s)
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Number of participants with nausea and vomiting
[Time Frame: Within the first 48 hours after surgery]
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Secondary Outcome(s)
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Nausea Scores on the Verbal Rating Scale
[Time Frame: Within the first 48 hours after surgery]
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Apgar Newborn
[Time Frame: delivery]
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Likert Scale
[Time Frame: 48 hours after surgery]
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Nausea Scores on the Number Rating Scale
[Time Frame: Within the first 48 hours after surgery]
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Number of participants with adverse events as a measure of safety and tolerability
[Time Frame: Within the first 48 hours after surgery]
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Number of participants with adverse events as a measure of safety and tolerability
[Time Frame: delivery]
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Secondary ID(s)
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Palonosetron01
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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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