Hypotension
Conditions
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.
Interventions
DRUGNorepinephrine
bolus administered norepinephrine 5mcg intravenously, if SBP \<90mmHg or 20% decrease from baseline
DRUGPhenylephrine
bolus administered phenylephrine 100mcg intravenously, if SBP \<90mmHg or 20% decrease from baseline
Sponsors
Jeju National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 45 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change of cardiac index (L/min/m2) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Change from Baseline at time 2, 3, 4, and 5 |
| 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 from Baseline at time 2, 3, 4, and 5 |
| 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 from Baseline at time 2, 3, 4, and 5 |
| 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 from Baseline at time 2, 3, 4, and 5 |
Other
| Measure | Time frame |
|---|---|
| Apgar score | 1 min after baby out, 5 min after baby out |
Countries
South Korea
Contacts
Primary ContactAE RYOUNG LEE
Backup ContactHyun Jung Kim
Outcome results
None listed