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The purpose of this study is to investigate the suitable infusion dose of norepinephrine for prophylaxis against 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. But the suitable infusion dose of norepinephrine in parturients with preeclampsia is still unknown. The purpose of this study is to investigate the suitable infusion dose of norepinephrine for prophylaxis against post-spinal anesthesia hypotension in parturients with preeclampsia undergoing cesarean section.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator | Normal saline infusion simultaneous with subarachnoid block |
|
| 0.025 μg/kg/min group | Experimental | A maintenance dose of norepinephrine (0.025 μg/kg/min) infusion simultaneous with subarachnoid block |
|
| 0.050 μg/kg/min group | Experimental | A maintenance dose of norepinephrine (0.050 μg/kg/min) infusion simultaneous with subarachnoid block |
|
| 0.075 μg/kg/min group | Experimental | A maintenance dose of norepinephrine (0.075 μg/kg/min) infusion simultaneous with subarachnoid block |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normal saline | Drug | Normal saline infusion simultaneous with subarachnoid block |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of post-spinal anesthesia hypotension | Systolic blood pressure (SBP) < 80% of the baseline | 1-15 minutes after spinal anesthesia. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall stability of systolic blood pressure control versus baseline | Evaluated by performance error (PE) | 1-15 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 | Affiliation | Role |
|---|---|---|
| Yi Chen, M.D. | General Hospital of Ningxia Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital of Ningxia Medical University | Yinchuan | Ningxia | 75004 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38869701 | Derived | Chen Y, Guo L, Qin R, Xi N, Wang S, Ma Y, Ni X. Dose-Response Study of Norepinephrine Infusion for Maternal Hypotension in Preeclamptic Patients Undergoing Cesarean Delivery Under Spinal Anesthesia. Clin Pharmacokinet. 2024 Jun;63(6):847-856. doi: 10.1007/s40262-024-01381-4. Epub 2024 Jun 13. |
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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 |
|---|---|
| D000077330 | Saline Solution |
| D009638 | Norepinephrine |
| D014662 | Vasoconstrictor Agents |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Norepinephrine | Drug | Different infusion dose of norepinephrine simultaneous with subarachnoid block |
|
|
Evaluated by performance error (PE)
| 1-15 minutes after spinal anesthesia |
| The incidence of severe post-spinal anesthesia hypotension | Systolic blood pressure (SBP) < 60% of the baseline | 1-15 minutes after spinal anesthesia |
| The incidence of nausea and vomiting | Presence of nausea and vomiting in patients after spinal anesthesia | 1-15 minutes after spinal anesthesia |
| The incidence of bradycardia | Heart rate < 55 beats/min | 1-15 minutes after spinal anesthesia |
| The incidence of hypertension. | Systolic blood pressure (SBP) >120% of the baseline. | 1-15 minutes after spinal anesthesia |
| pH | From umbilical arterial blood gases. | Immediately after delivery |
| Partial pressure of oxygen | From umbilical arterial blood gases. | Immediately after delivery |
| Base excess | 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 |
| D004983 |
| Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| 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 |
| D002317 | Cardiovascular Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |