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The purpose of this study is to investigate the suitable infusion dose of norepinephrine for prophylaxis against post-spinal anesthesia hypotension.
Post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for cesarean section. The incidence of post-spinal anesthesia hypotension is as high as 62.1-89.7% if prophylactic measures are not taken. Vasopressors has been highly recommended for routine prevention and/or treatment of post-spinal anesthesia hypotension. As a potential substitute drug for phenylephrine, norepinephrine has gradually been used in parturients undergoing cesarean section. There's some evidence that prophylactic infusion of norepinephrine could effectively reduce the incidence of post-spinal anesthesia hypotension in parturients undergoing cesarean section. But the ideal infusion dose of norepinephrine is still unknown. The purpose of this study is to investigate the suitable infusion dose of norepinephrine for prophylaxis against post-spinal anesthesia hypotension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Sham Comparator | Simultaneous with subarachnoid block, a bolus of 1ml normal saline was given followed by normal saline infusion |
|
| 0.025 μg/kg/min group | Experimental | Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by a maintenance dose of norepinephrine (0.025 μg/kg/min). |
|
| 0.05 μg/kg/min group | Experimental | Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by a maintenance dose of norepinephrine (0.05 μg/kg/min). |
|
| 0.075 μg/kg/min group | Experimental | Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by a maintenance dose of norepinephrine (0.075 μg/kg/min). |
|
| 0.1 μg/kg/min group | Experimental | Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by a maintenance dose of norepinephrine (0.1 μg/kg/min). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Norepinephrine | Drug | Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by different infusion dose of norepinephrine. |
|
| 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 |
|---|---|---|
| Xinli Ni, Dr. | General Hospital of Ningxia Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital of Ningxia Medical University | Yinchuan | Ningxia | 750004 | China |
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| ID | Term |
|---|---|
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D009638 | Norepinephrine |
| D014662 | Vasoconstrictor Agents |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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|
| Normal saline | Drug | Simultaneous with subarachnoid block, a bolus of 1ml normal saline was given followed by normal saline infusion |
|
|
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 | 1min after delivery |
| APGAR score | A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration | 5min after delivery |
| 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 |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |