NCT03182088

Norepinephrine Infusion Different Doses in Cesarean Delivery

Norepinephrine Infusion for Prevention of Post-spinal Hypotension During Cesarean Delivery: A Randomized Controlled Dose Finding Trial.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 284 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

three doses (0.025 mcg/Kg/min, 0.050 mcg/Kg/min, and 0.075 mcg/Kg/min) of norepinephrine will be compared for prophylaxis against Post-spinal anesthesia 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 agonist activity in addition to a weak β adrenergic agonist 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, three doses (0.025, 0.050, 0.075 mcg/Kg/min) of norepinephrine will be compared for prophylaxis against PSH during CD.

Conditions

• Cesarean Section Complications

Interventions

Type	Name	Description
DRUG	norepinephrine infusion (0.025 mcg/Kg/min)	The patients will receive a bolus of 5 mcg norepinephrine followed by norepinephrine bitartrate infusion of (0.05 mcg/Kg/min) equivalent to norepinephrine base of (0.025 mcg/Kg/min)
DRUG	norepinephrine infusion (0.050 mcg/Kg/min)	The patients will receive a bolus of 5 mcg norepinephrine followed by norepinephrine infusion of (0.1 mcg/Kg/min) equivalent to norepinephrine base of (0.050 mcg/Kg/min)
DRUG	norepinephrine infusion (0.075 mcg/Kg/min)	The patients will receive a bolus of 5 mcg norepinephrine followed by norepinephrine infusion of (0.15 mcg/Kg/min) equivalent to norepinephrine base of (0.075 mcg/Kg/min).
DRUG	Bupivacaine	The patient will receive spinal anesthesia using Bupivacaine (10 mg).

Timeline

• Start date: 2017-06-15
• Primary completion: 2017-12-25
• Completion: 2017-12-30
• First posted: 2017-06-09
• Last updated: 2018-08-24

Locations

1 site across 1 country: Egypt