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Clinical trial

Epinephrine Versus Phenylephrine Infusion for Prophylaxis Against Maternal Hypotension After Spinal Anesthesia for Cesarean Delivery: a Randomized Controlled Trial.

ID
Name
MD-245-2022
Description
Subarachnoid block is the common route of anesthesia for cesarean delivery. Maternal hypotension after subarachnoid block is very common despite the vigorous methods for its prevention. Maternal hypotension is sometimes deleterious to the mother and the fetus; thus, it is highly recommended to use prophylactic vasopressors directly after the block and before the blood pressure drops. The aim of this work is to compare the maternal and neonatal effects of epinephrine and phenylephrine when used as prophylactic infusion after subarachnoid block for cesarean delivery.
Trial arms
Trial start
2023-06-01
Estimated PCD
2023-12-01
Trial end
2023-12-01
Status
Completed
Treatment
Phenylephrine
phenylephrine infusion at rate of 0.4 mcg/Kg/min. (10 mg /1 mL) will be diluted to reach a final concentration of 10 mcg/mL
Arms:
phenylephrine
Epinephrine
epinephrine infusion dose of 0.03 mcg/Kg/min. epinephrine (1mg/ 1mL ampoule) will be diluted to reach a final concentration of 10 mcg/ml.
Arms:
epinephrine
Size
196
Primary endpoint
incidence of post spinal hypotension
from spinal anesthesia till delivery of fetus (about 45-60 mins)
Eligibility criteria
Inclusion Criteria: * full-term singleton pregnant women, admitted for elective cesarean delivery * aged between 18 and 40 years Exclusion Criteria: * Patients with uncontrolled cardiac morbidities, hypertensive disorders of pregnancy * Peripartum bleeding * coagulation disorders * Baseline systolic blood pressure (SBP) \< 100 mmHg
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 196, 'type': 'ACTUAL'}}
Updated at
2024-02-28

1 organization

2 products

1 indication

Organization
Cairo University
Product
Phenylephrine
Indication
Hypotension during surgery
Product
Epinephrine