drugset / Trial / NCT02477501

Ephedrine vs. Nor Epinephrine Infusion in Preventing Hypotension After Spinal Anesthesia for Cesarean Section

NCT02477501

Phase 4 Completed 120 enrolled University Tunis El Manar
RandomizedParallel-groupTriple-blindPrevention

Summary

The purpose of the study is to determine if norepinephrine is more effective as a continuous intravenous (IV) infusion compared to continuous IV ephedrine associated with crystalloid loading for maintaining blood pressure during a spinal anesthetic for a cesarean delivery. Prevention of low blood pressure has been shown to decrease nausea and vomiting during and after cesarean delivery under spinal anesthesia. For elective cesarean delivery, all participants will receive spinal anesthesia with a local anesthetic and morphine. This study plans to enroll 120 pregnant women. Patients will be randomly assigned according to a computer generated system to be in one of two groups.

Timeline

Start
2016-01
Primary completion
2016-11
Completion
2016-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ephedrine Small molecule 10 ug/kg Intravenous
Comparator Norepinephrine Other / unclassified 0.1 ug/kg Intravenous

Indications