NCT03234816

Vasopressor Prophylaxis After Spinal Anesthesia

Vasopressor Prophylaxis After Spinal Anesthesia: A Dose Finding Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 270 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

Norepinephrine has been recently introduced as a prophylactic vasopressor during Cesarean delivery with promising results ; However, the optimum dose for efficient prophylaxis with the least side effects is not known. In this study, we will compare three doses (0.05, 0.1, 0.15 mcg/Kg/min) of norepinephrine for prophylaxis against Post-Spinal hypotension during cesarean delivery.

Detailed description

Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery (CD). Using vasopressors have been considered a gold standard for prevention of post-spinal hypotension (PSH) during CD. 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 phenylephrine and ephedrine (the most commonly used vasopressors in obstetric anesthesia). Norepinephrine has been recently introduced as a prophylactic vasopressor during CD with promising results; However, the optimum dose for efficient prophylaxis with the least side effects is not known. In this study, we will compare three doses (0.05, 0.1, 0.15 mcg/Kg/min) of norepinephrine for prophylaxis against PSH during CD.

Conditions

• Cesarean Section Complications

Interventions

Type	Name	Description
DRUG	Norepinephrine 0.05 mcg /Kg/min	Norepinephrine infusion by rate of 0.05 mcg /Kg/min after spinal anesthesia
DRUG	Norepinephrine 0.1 mcg /Kg/min	Norepinephrine infusion by rate of 0.05 mcg /Kg/min after spinal anesthesia
DRUG	Norepinephrine 0.15 mcg /Kg/min	Norepinephrine infusion by rate of 0.05 mcg /Kg/min after spinal anesthesia
DRUG	Bupivacaine	10 mg Bupivacaine intra-thecal for spinal anesthesia

Timeline

• Start date: 2017-08-02
• Primary completion: 2018-11-02
• Completion: 2018-12-10
• First posted: 2017-07-31
• Last updated: 2019-01-15

Locations

1 site across 1 country: Egypt