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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: |
NCT02958215 |
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Date of registration:
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04/11/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Phenylephrine and Hypotension During Spinal Anesthesia for Cesarean Section
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Scientific title:
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A Study Evaluating Hypotension and Autonomic Nervous System Dysfunction During Spinal Anesthesia for Cesarean Section and Its Relation to the Effect of Prophylaxis Phenylephrine |
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Date of first enrolment:
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June 2016 |
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Target sample size:
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980 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02958215 |
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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: Triple (Participant, Care Provider, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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Egypt
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Contacts
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Name:
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Sayed K Abd-Elshafy, 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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Associate professor of anesthesia |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Physical status ASA I, A full term pregnancy A single fetus Elective cesarean section.
Exclusion Criteria:
Refusal of the patient to participate in the study History of hypertension
Pregnancy-induced hypertension Cardiovascular or cerebrovascular disease Fetal
abnormalities History of hypersensitivity to the drugs used Contraindications to spinal
block.
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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Anesthesia, Obstetrical
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Anesthesia, Spinal
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Intervention(s)
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Drug: Phenylephrine
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Other: Placebo
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Primary Outcome(s)
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Incidence of hypotension
[Time Frame: within first 24 hours after spinal anesthesia]
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Secondary Outcome(s)
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Ephedrine usage
[Time Frame: within first 24 hours after spinal anesthesia]
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Frequency of bradycardia
[Time Frame: within first 24 hours after spinal anesthesia]
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intraoperative fluid management
[Time Frame: within first 24 hours after spinal anesthesia]
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Apgar scores
[Time Frame: within first 24 hours after spinal anesthesia]
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Secondary ID(s)
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IRB0000871230
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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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