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Ephedrine vs. Norepinephrine for Hypotension during Cesarean Section
NCT02477501Phase 4
Key facts
- Status
- Completed
- Start
- Jan 2016
- Primary completion
- Nov 2016
- Countries
- 1
- Sponsor
- University of Tunis El Manar
- Modality
- Small Molecules
- Drugs
- norepinephrine
- Conditions
- hypotension
01
Overview
Phase 4, randomised, double-blind trial of norepinephrine in hypotension (2 arms), sponsored by University of Tunis El Manar. Primary endpoint: Number of provider interventions needed to maintain SBP within 100-120% of baseline. Started Jan 2016; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Ephedrine
Continuous Ephedrine infusion 10 mcg/kg/min
Norepinephrine
Continuous Norepinephrine infusion 0.1 mcg/kg/min
03
Who it enrols
Pregnant women >36 weeks with singleton pregnancy undergoing elective cesarean section under spinal anesthesia, ASA 1-2. Excludes cardiovascular disease, insulin-dependent diabetes, preeclampsia, and chronic opioid use.
04
Endpoints
Primary
Number of provider interventions needed to maintain SBP within 100-120% of baseline
Secondary
Incidence of Nausea
Incidence of Vomiting
Hemodynamic Parameters - Heart Rate
Incidence of Arrhythmia
Mean pH of Fetal Cord Blood
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