drugset / Trial / NCT03704909

Manging Post Spinal Hypotension During Elective Cesarean Section

NCT03704909

Phase 4 Completed 143 enrolled Ben marzouk Sofiene
RandomizedParallel-groupTriple-blindPrevention

Summary

Spinal anesthesia is the gold standard technique for elective cesarean section. It helps to avoid risks regarding airway management and provides effective neuraxial postoperative analgesia, enabling quicker maternal recovery. Cesarean section normally require an anesthetic block at T4 level. So that maternal hypotension is reported to occur in up to 80%. This can result in significant morbidity for both the mother and fetus.The purpose of this study is to determine if epinephrine is as effective and safe compared to ephedrine for maintaining arterial blood pressure during elective cesarean section under spinal anesthesia. All participants will receive spinal anesthesia with a local anesthetic and sufentanil. This study plans to enroll 140 healthy pregnant women. Patients will be randomly assigned according to a computer generated system to be in one of two groups.

Timeline

Start
2018-09-01
Primary completion
2018-12-31
Completion
2018-12-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ephedrine Small molecule 0.1 mg/kg Intravenous
Comparator Epinephrine Other / unclassified 0.15 ug/kg Intravenous

Indications