Norepinephrine and Phenylephrine for Cesarean Section
Trial Snapshot
- Phase
- Phase 4
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- change of cardiac index (L/min/m2)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 19 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
norepinephrine
norepinephrine 5mcg intravenously administered
Intervention: Norepinephrine (Drug)
phenylephrine
phenylephrine 100mcg intravenously administered
Intervention: Phenylephrine (Drug)
Outcomes
Primary Outcomes
change of cardiac index (L/min/m2)
Time Frame: 1. initial (baseline); 2. 20 min after spinal anesthesia; 3. 1min after the surgery; 4. 1min after baby out; 5. 1min after the end of surgery
Change from Baseline at time 2, 3, 4, and 5
Secondary Outcomes
- change of heart rate (beats per minute)(1. initial (baseline); 2. 20 min after spinal anesthesia; 3. 1min after the surgery; 4. 1min after baby out; 5. 1min after the end of surgery)
- change of Systolic blood pressure (mmHg)(1. initial (baseline); 2. 20 min after spinal anesthesia; 3. begin the surgery; 4. baby out; 5. the end of surgery)
- change of Total Peripheral Resistance (dynes sec/cm3)(1. initial (baseline); 2. 20 min after spinal anesthesia; 3. 1min after the surgery; 4. 1min after baby out; 5. 1min after the end of surgery)
- change of Stroke volume (ml/beat)(1. initial (baseline); 2. 20 min after spinal anesthesia; 3. 1min after the surgery; 4. 1min after baby out; 5. 1min after the end of surgery)
Investigators
Ae ryoung Lee
Assistant Professor
Jeju National University Hospital