NCT03702400

Norepinephrine or Phenylephrine in Bolus for Hypotension in Cesarean Delivery

Randomized Double-blinded Comparison of Norepinephrine and Phenylephrine in Bolus for Maintenance of Blood Pressure During Spinal Anesthesia for Cesarean Delivery

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Hospital dos Servidores do Estado do Rio de Janeiro · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study evaluate the ability of phenylephrine and of noradrenaline to maintain normal systemic arterial blood pressure and heart rate in healthy pregnant women submitted to cesarean section with spinal anesthesia. Half of participants will receive bolus of phenylephrine while the other half will receive bolus of noradrenaline.

Detailed description

This is a prospective, randomized, double-blind, comparative two-group clinical study to observe two vasopressor drugs, phenylephrine and noradrenaline, in the ability to maintain systemic arterial pressure in pregnant women after spinal anesthesia for cesarean section; based on the hypothesis that, since noradrenaline has a predominant alpha-adrenergic action and a weak 1- beta-adrenergic beta action, it could be as capable of maintaining blood pressure effectively as phenylephrine, but with a lower frequency of bradycardia; patients who meet the inclusion criteria will be randomly assigned to one of the groups to be studied: group F - phenylephrine at a dose of 100mcg bolus and N - noradrenaline at the dose of 5mcg. One of these drugs will be used whenever systolic blood pressure drops below 10% of the baseline, additional doses will be allowed whenever necessary, aiming at maintaining the systolic blood pressure at baseline values; the blood pressure will be measured non-invasively and the heart rate by pulse oximeter and electrocardiogram.

Conditions

• Hypotension
• Spinal Anesthesia

Interventions

Type	Name	Description
DRUG	Phenylephrine 100 mcg	Phenylephrine at a dose of 100 mcg bolus at a dilution containing 20 mcg / mL of the drug, 5 mL each bolus
DRUG	Norepinephrine 5 mcg	Norepinephrine at a dose of 5 mcg at dilution containing 1 mcg / mL, 5 mL each bolus

Timeline

• Start date: 2018-10-01
• Primary completion: 2020-06-01
• Completion: 2020-10-01
• First posted: 2018-10-11
• Last updated: 2021-04-13

Locations

1 site across 1 country: Brazil

Regulatory

• FDA-regulated drug study