NCT03328533

Norepinephrine Versus Phenylephrine Continuous Variable Infusion in Cesarean Delivery

Norepinephrine Versus Phenylephrine Continuous Variable Infusion for Prevention of Post-spinal Hypotension During Cesarean Delivery: A Randomized Controlled Double-blinded Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

Comparison will be conducted between continuous variable infusions of Phenylephrine with starting dose of 0.75 mcg/Kg/min and Norepinephrine Bitartrate with starting dose of 0.1 mcg/Kg/min (with norepinephrine base of 0.05 mcg/Kg/min) for prophylaxis against Post-spinal hypotension during cesarean delivery

Detailed description

Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery (CD). Many vasopressors have been used for prevention of post-spinal hypotension (PSH) during CD; however, the optimum protocol for prophylaxis is not established yet. Phenylephrine (PE) is a popular vasopressor used in obstetric anesthesia; however, its use is limited by its marked cardiac depressant nature. Norepinephrine (NE) is a potent vasopressor characterized by both α adrenergic agonistic activity in addition to a weak β adrenergic agonistic activity; thus, NE is considered a vasopressor with minimal cardiac depressant effect; these pharmacological properties would make NE an attractive alternative to PE. In this study, the investigators will compare continuous variable infusion of both drugs (PE and NE) with doses of 0.75 mcg/Kg/min and 0.05 mcg/Kg/min respectively for prophylaxis against PSH during CD. We used Norepinephrine Bitartrate 8 mg ampules which contains norepinephrine base of 4 mg.

Conditions

• Cesarean Section Complications
• Spinal Anesthesia

Interventions

Type	Name	Description
DRUG	Phenylephrine	Phenylephrine variable infusion with a starting rate of 0.75 mcg/Kg/min.
DRUG	Norepinephrine	Norepinephrine bitartrate variable infusion with a starting rate of 0.1 mcg/Kg/min (equivalent to norepinephrine base of 0.05 mcg/Kg/min).
DRUG	Bupivacaine	Bupivacaine will be injected in the subarachnoid space with a dose of 10 mg.

Timeline

• Start date: 2017-11-10
• Primary completion: 2018-05-01
• Completion: 2018-05-05
• First posted: 2017-11-01
• Last updated: 2018-07-17

Locations

1 site across 1 country: Egypt