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The purpose of this study is to investigate the maternal cardiac output response to prophylactic norepinephrine and phenylephrine infusion for postspinal anesthesia hypotension in parturients with preeclampsia undergoing cesarean section.
Preeclampsia, which affects 5% to 7% of parturients, is a significant cause of maternal and neonatal morbidity and mortality. Because of constricted myometrial spiral arteries with exaggerated vasomotor responsiveness, though blood pressure in parturients with preeclampsia are apparently higher than healthy parturients, placental hypoperfusion is more common. Spinal anesthesia is still the preferred mode of anesthesia in parturients with preeclampsia for cesarean section. In preeclampsia parturients, spinal anesthesia improve intervillous blood flow (provided that hypotension is avoided) which contribute to increase placental perfusion. Even so, 17-26% parturients with preeclampsia experienced postspinal anesthesia hypotension due to the extensive sympathetic block that occurred with spinal anesthesia. As a potential substitute drug for phenylephrine and ephedrine, norepinephrine has gained traction for use in parturients undergoing cesarean section. However, hemodynamic effects of the prophylactic norepinephrine infusion is still unknown. The purpose of this study is to investigate the maternal cardiac output response to prophylactic norepinephrine and phenylephrine infusion for postspinal anesthesia hypotension in parturients with preeclampsia undergoing cesarean section.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phenylephrine group | Active Comparator | Phenylephrine infusion simultaneous with spinal anesthesia |
|
| Norepinephrine group | Experimental | Norepinephrine infusion simultaneous with spinal anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phenylephrine | Drug | A maintenance dose of phenylephrine (0.625 μg/kg/min) infusion simultaneous with subarachnoid block |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac output (CO) | Evaluated by the VIGILCO monitoring system | 1-30 minutes after spinal anesthesia |
| Stroke volume (SV) | Evaluated by the VIGILCO monitoring system | 1-30 minutes after spinal anesthesia |
| Systemic vascular resistance (SVR) | Evaluated by the VIGILCO monitoring system | 1-30 minutes after spinal anesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| Overall stability of systolic blood pressure control versus baseline | Evaluated by performance error (PE) | 1-30 minutes after spinal anesthesia |
| Overall stability of heart rate control versus baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xinli Ni, Dr. | Contact | 86-951-674-3252 | xinlini6@nyfy.com.cn | |
| Yi Chen, M.D. | Contact | 86-951-674-3252 | czzyxgp@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xinli Ni, Dr. | General Hospital of Ningxia Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital of Ningxia Medical University | Recruiting | Yinchuan | Ningxia | 750004 | China |
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| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D010656 | Phenylephrine |
| D014662 | Vasoconstrictor Agents |
| D009638 | Norepinephrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Norepinephrine | Drug | A maintenance dose of norepinephrine (0.05 μg/kg/min) infusion simultaneous with subarachnoid block |
|
|
Evaluated by performance error (PE)
| 1-30 minutes after spinal anesthesia |
| The incidence of post-spinal anesthesia hypotension | Systolic blood pressure (SBP) < 80% of the baseline | 1-30 minutes after spinal anesthesia. |
| The incidence of severe post-spinal anesthesia hypotension. | Systolic blood pressure (SBP) < 60% of the baseline | 1-30 minutes after spinal anesthesia. |
| The incidence of hypertension. | Systolic blood pressure (SBP) >120% of the baseline. | 1-30 minutes after spinal anesthesia |
| The incidence of bradycardia. | Heart rate < 60 beats/min. | 1-30 minutes after spinal anesthesia |
| The incidence of nausea and vomiting. | Presence of nausea and vomiting in patients after spinal anesthesia | 1-30 minutes after spinal anesthesia |
| pH | From umbilical arterial blood gases. | Immediately after delivery |
| Partial pressure of oxygen (PO2) | From umbilical arterial blood gases. | Immediately after delivery |
| Base excess (BE) | From umbilical arterial blood gases. | Immediately after delivery |
| APGAR score | A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration | 1 min after delivery |
| APGAR score | A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration | 5 min after delivery |
| D000588 |
| Amines |
| D002317 | Cardiovascular Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |