CLINICAL TRIALS PROFILE FOR NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE

All Clinical Trials for norepinephrine bitartrate in 0.9% sodium chloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02654847 ↗	Norepinephrine To Prevent Hypotension After Spinal Anesthesia For Cesarean Delivery: A Dose Finding Study	Completed	Samuel Lunenfeld Research Institute, Mount Sinai Hospital	N/A	2016-01-01	Spinal anesthesia is the most common anesthetic technique for elective Cesarean delivery (CD), but the most frequent unwanted side effect is hypotension, which can cause nausea and vomiting, as well as effects on the fetus. Prevention and treatment of maternal hypotension includes intravenous fluids and vasopressors. Phenylephrine is the most common vasopressor used for this purpose. However, it has been shown to reduce maternal heart rate and cardiac output, which may be a concern in an already compromised fetus. Norepinephrine is commonly used in high concentrations in intensive care and recent studies have suggested that in low concentrations it may be a better alternative to phenylephrine in elective CD, as it does not reduce the maternal heart rate or cardiac output. The optimum bolus dose of norepinephrine to prevent hypotension after spinal anesthesia in elective CD has not been elucidated. The investigators propose this study to determine the dose that would be effective in 90% of patients (ED90). A previous study by Ngan Kee et al, using continuous infusion of norepinephrine to prevent hypotension in elective CD, suggested a potency ratio for norepinephrine to phenylephrine of approximately 16:1. Hence, the investigators hypothesise that the ED90 will be approximately 6 µg, given that the current phenylephrine bolus dose at the investigators' institution is approximately 100 µg.
NCT02962986 ↗	A Comparison of Intermittent Intravenous Boluses of Phenylephrine and Norepinephrine to Prevent Spinal-induced Hypotension in Cesarean Deliveries	Completed	Samuel Lunenfeld Research Institute, Mount Sinai Hospital	N/A	2017-01-01	Hypotension is a very common complication of spinal anesthesia for cesarean delivery, and can have unwanted side effects on both mother and fetus if not treated promptly. Phenylephrine has been the drug of choice to treat this spinal-induced hypotension. Although phenylephrine is safe to use for this indication, it has been associated with reflex bradycardia and a reduction in cardiac output. Norepinephrine is a potent vasopressor used to treat hypotension in the critical care setting. Recent studies have looked at norepinephrine's use in the obstetric setting, and have shown that it can be used safely and also has favourable hemodynamic properties when compared to phenylephrine, with less bradycardia and less depression of cardiac output. The investigators recently conducted a study to determine the ED90 of norepinephrine, and now plan to compare bolus doses of phenylephrine to norepinephrine for treating hypotension following spinal anesthesia for cesarean section. The investigators hypothesize that norepinephrine, when given as a bolus to prevent post spinal hypotension, will result in around 70% relative decrease in the rate of bradycardia when compared to phenylephrine in patients undergoing elective cesarean delivery under spinal anesthesia.
NCT03328533 ↗	Norepinephrine Versus Phenylephrine Continuous Variable Infusion in Cesarean Delivery	Completed	Cairo University	Phase 4	2017-11-10	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

Clinical Trial Conditions for norepinephrine bitartrate in 0.9% sodium chloride

Condition Name

Condition Name for norepinephrine bitartrate in 0.9% sodium chloride
Intervention	Trials
Hypotension	3
Anesthesia	2
Cesarean Section Complications	2

Condition MeSH

Condition MeSH for norepinephrine bitartrate in 0.9% sodium chloride
Intervention	Trials
Hypotension	6
Toxemia	1
Sepsis	1

Clinical Trial Locations for norepinephrine bitartrate in 0.9% sodium chloride

Trials by Country

Trials by Country for norepinephrine bitartrate in 0.9% sodium chloride
Location	Trials
Canada	3
Egypt	2
Tunisia	2
China	1
United States	1

Trials by US State

Trials by US State for norepinephrine bitartrate in 0.9% sodium chloride
Location	Trials
Ohio	1

Clinical Trial Progress for norepinephrine bitartrate in 0.9% sodium chloride

Clinical Trial Phase

Clinical Trial Phase for norepinephrine bitartrate in 0.9% sodium chloride
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	2
N/A	3

Clinical Trial Status

Clinical Trial Status for norepinephrine bitartrate in 0.9% sodium chloride
Clinical Trial Phase	Trials
Completed	4
Recruiting	3
Not yet recruiting	2

Clinical Trial Sponsors for norepinephrine bitartrate in 0.9% sodium chloride

Sponsor Name

Sponsor Name for norepinephrine bitartrate in 0.9% sodium chloride
Sponsor	Trials
Samuel Lunenfeld Research Institute, Mount Sinai Hospital	2
Kasr El Aini Hospital	1
Second Affiliated Hospital, School of Medicine, Zhejiang University	1

Sponsor Type

Sponsor Type for norepinephrine bitartrate in 0.9% sodium chloride
Sponsor	Trials
Other	9