NCT02962986

A Comparison of Intermittent Intravenous Boluses of Phenylephrine and Norepinephrine to Prevent Spinal-induced Hypotension in Cesarean Deliveries

A Comparison of Intermittent Intravenous Boluses of Phenylephrine and Norepinephrine to Prevent Spinal-induced Hypotension in Cesarean Deliveries: a Randomized Controlled Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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. These studies have been limited to using norepinephrine as an infusion and there is limited data with it being used as a bolus to prevent hypotension. A recent study was undertaken at Mount Sinai hospital to determine the ED90 of norepinephrine to treat post spinal hypotension. Secondary outcome data from this trial showed that the incidence of bradycardia associated with this treatment is approximately 7.5%, several times less when compared to the reported 30% with phenylephrine. It would therefore be prudent at this stage to undertake a randomized trial comparing the hemodynamic profile of phenylephrine (our standard practice) and norepinephrine used as intermittent boluses to prevent hypotension and avoid decrease in heart rate during cesarean delivery.

Conditions

• Hypotension

Interventions

Type	Name	Description
DRUG	Norepinephrine	Norepinephrine diluted in 5% dextrose solution to a concentration of 6mcg/mL
DRUG	Phenylephrine	Phenylephrine diluted in 0.9% normal saline solution to a concentration of 100mcg/mL

Timeline

• Start date: 2017-01-01
• Primary completion: 2017-04-01
• Completion: 2017-04-01
• First posted: 2016-11-15
• Last updated: 2017-05-24

Locations

1 site across 1 country: Canada