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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: |
NCT02737813 |
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Date of registration:
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23/03/2016 |
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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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Cardiac Output Changes During Hyperbaric and Isobaric Bupivacaine in Patients Undergoing Cesarean Section
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Scientific title:
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Cardiac Output Changes During Hyperbaric and Isobaric Bupivacaine in Patients Undergoing Cesarean Section: An Randomization Trials |
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Date of first enrolment:
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March 29, 2016 |
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Target sample size:
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168 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02737813 |
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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: Treatment. 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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Thailand
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Contacts
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Name:
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Sirilak Suksompong, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mahidol University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- American Society of Anesthesiology classification I - II
- Elective or urgency Cesarean section with spinal block e.g. cephalopelvic
disproportion, premature rupture of membrane
- Singleton pregnancy
- Body mass index < 40 kg/m2
Exclusion Criteria:
- Pregnancy <35 weeks gestational age
- Hypertensive disease e.g. gestational hypertension, chronic hypertension, preeclampsia
- History of allergy to the study drugs
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, Spinal
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Hypotension
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Cardiac Output
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Intervention(s)
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Drug: Isobaric marcaine
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Drug: Hyperbaric marcaine
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Primary Outcome(s)
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Change of cardiac output (L/min) after spinal block
[Time Frame: 5 minutes after spinal block]
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Secondary Outcome(s)
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Number of patients who experience systolic blood pressure < 25% of preoperative measurement
[Time Frame: 2 hours]
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Total dose of vasopressor
[Time Frame: 2 hours]
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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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