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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| norepinephrine | Experimental | norepinephrine 5mcg intravenously administered |
|
| phenylephrine | Active Comparator | phenylephrine 100mcg intravenously administered |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Norepinephrine | Drug | bolus administered norepinephrine 5mcg intravenously, if SBP <90mmHg or 20% decrease from baseline |
|
| Measure | Description | Time Frame |
|---|---|---|
| change of cardiac index (L/min/m2) | Change from Baseline at time 2, 3, 4, and 5 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| change of Stroke volume (ml/beat) | Change from Baseline at time 2, 3, 4, and 5 | 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 Total Peripheral Resistance (dynes sec/cm3) |
| Measure | Description | Time Frame |
|---|---|---|
| Apgar score | 1 min after baby out, 5 min after baby out |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AE RYOUNG LEE | Contact | +82647171810 | nanrong95@naver.com | |
| Hyun Jung Kim | Contact | +82647172031 | aeryoung.lee@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| AE RYOUNG LEE | Jeju National University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jeju National University Hospital | Recruiting | Jeju City | Jeju-do | 690-767 | South Korea |
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| ID | Term |
|---|---|
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D009638 | Norepinephrine |
| D010656 | Phenylephrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Phenylephrine | Drug | bolus administered phenylephrine 100mcg intravenously, if SBP <90mmHg or 20% decrease from baseline |
|
|
Change from Baseline at time 2, 3, 4, and 5 |
| 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) | Change from Baseline at time 2, 3, 4, and 5 | 1. initial (baseline); 2. 20 min after spinal anesthesia; 3. begin the surgery; 4. baby out; 5. the end of surgery |
| change of heart rate (beats per minute) | Change from Baseline at time 2, 3, 4, and 5 | 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 |
| D000588 |
| Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |