NCT02969239

Norepinephrine and Phenylephrine for Maternal Cardiac Output During Spinal Anesthesia for Elective Cesarean Delivery

Norepinephrine and Phenylephrine for Cesarean Section

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Jeju National University Hospital · Academic / Other
• Sex: Female
• Age: 19 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare norepinephrine and phenylephrine on the effects of maintaining the cardiac output in Cesarean section under spinal anesthesia.

Detailed description

CO was measured using the NICOM® monitor. Bioreactance, a development from impedance technology, is also emerging as an accessible mode of continuous CO monitoring in the operating room and can provide valuable insight into the hemodynamic effects of our interventions. This method of monitoring provides continuous CO, stroke volume (SV) and heart rate (HR) monitoring, and intermittent BP and SVR assessments at 1-minute intervals. Either phenylephrine (100 mcg/ml) or norepinephrine (0.5 mcg/ml) in 50-ml syringe that were labeled "study drug". She was not involved in patient's care or study assessment. The hypotension was defined as systolic blood pressure \<80% of baseline or \< 90 mmHg, and managed with study drug (1 ml) intravenously. The bradycardia was defined as HR \< 60 beats/min and was recorded and managed with atropine (0.5 mg) intravenously as HR \< 45 beats/min. The presence of nausea and vomiting was measured on a 3 point scale (1 = no nausea and vomiting, 2 = nausea only, and 3 = both nausea and vomiting) and managed with ondansetron (4mg) intravenously.

Conditions

• Hypotension

Interventions

Type	Name	Description
DRUG	Norepinephrine	bolus administered norepinephrine 5mcg intravenously, if SBP \<90mmHg or 20% decrease from baseline
DRUG	Phenylephrine	bolus administered phenylephrine 100mcg intravenously, if SBP \<90mmHg or 20% decrease from baseline

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-07-01
• Completion: 2017-07-01
• First posted: 2016-11-21
• Last updated: 2017-03-10

Locations

1 site across 1 country: South Korea