NCT03248791

Vasopressor Infusion in Cesarean Delivery

Comparison of Two Vasopressor Infusion for Prevention of Post-spinal Hypotension During Cesarean Delivery: A Randomized Controlled Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• 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 both drugs (Phenylephrine and Norepinephrine) with starting doses of 0.75 mcg/Kg/min and 0.1 mcg/Kg/min respectively 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, we will compare continuous variable infusion of both drugs (PE and NE) with doses of 0.75 mcg/Kg/min and 0.1 mcg/Kg/min respectively for prophylaxis against PSH during CD.

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 variable infusion with a starting rate of 0.1 mcg/Kg/min.
DRUG	Bupivacaine	Bupivacaine will be injected in the subarachnoid space with a dose of 10 mg

Timeline

• Start date: 2017-08-20
• Primary completion: 2022-03-01
• Completion: 2022-03-10
• First posted: 2017-08-14
• Last updated: 2021-09-27

Locations

1 site across 1 country: Egypt