Status:
COMPLETED
Phenylephrine Versus Norepinephrine for Maintenance of Hemodynamic During Cesarean Section Under Spinal Anesthesia
Lead Sponsor:
Centre Hospitalier Régional d'Orléans
Conditions:
Cesarean Section Complications
Spinal Anesthesia
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
Comparison between prophylactic continuous variable infusion of phenylephrine (starting dose 0,5mcg/kg/min) and norepinephrine tartrate (starting dose 0,1mcg/kg/min) to prevent hypotension and maintai...
Detailed Description
Maternal hypotension is a frequent complication after spinal anesthesia for cesarean delivery. Many vasopressors have been studied and used, but the perfect vasopressor is yet to be found. Phenylephri...
Eligibility Criteria
Inclusion
- Pregnancy higher than 36 weeks of amenorrhea
- Scheduled or semi-urgent (interval between decision and delivery by cesarean section higher than 12hours) cesarean section under spinal anesthesia
Exclusion
- Extreme height (less than 140cm; higher than 180cm)
- Weight less than 50kg
- Weight higher than 120kg
- Cardiovascular disease with use of cardiac medication (including antihypertensive drug)
- Active neurological disease
- Anti-hypertension treatment.
- High blood pressure or severe pre-eclampsia
- American Society of Anesthesiologists physical status class higher than 3
- Placenta accrete/percreta
- Cesarean section scheduled under general anesthesia
- Contraindications to spinal anesthesia
- Minor (age less than 18 years old)
- Guardianship/ curatorship
- Anemia less than or equal to 8 g/dl
- Allergy to any study medication
- Simultaneous participation in another study
Key Trial Info
Start Date :
February 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 2 2020
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT03849508
Start Date
February 27 2019
End Date
December 2 2020
Last Update
May 27 2021
Active Locations (1)
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1
Regional Hospital Center of ORLEANS
Orléans, France, 45067