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

Jeju National University Hospital

Status and phase: Unknown; Phase 4

Conditions: Hypotension

Treatments: Drug: Norepinephrine; Drug: Phenylephrine

Study type: Interventional

Funder types: Other

Identifiers

NCT02969239

ALee-OB-2016-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 19 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ASA class I and II, term pregnancy (gestational age>37weeks), planned spinal anesthesia for elective cesarean section

Exclusion criteria

• preexisting or gestational hypertension, cerebrovascular or cardiovascular disease, any contraindication to the spinal anesthesia, fetal anormaly, weight<50kg or >100kg, and height<140cm or >180cm.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups

norepinephrine

Experimental group

Description:

norepinephrine 5mcg intravenously administered

Treatment:

Drug: Norepinephrine

phenylephrine

Active Comparator group

Description:

phenylephrine 100mcg intravenously administered

Treatment:

Drug: Phenylephrine