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Hypotension is a very common consequence of the sympathetic vasomotor block caused by spinal anesthesia for cesarean section. Maternal symptoms such as nausea, vomiting and dyspnea frequently accompany severe hypotension, and adverse effects on the fetus, including depressed APGAR scores and umbilical acidosis, have been correlated with severity and duration of hypotension. Because hypotension is frequent, vasopressors should be used routinely and preferably prophylactically.
Phenylephrine has a potent direct α effect, with virtually no β effects at clinical doses, however when given at higher than required doses, it may induce baroreceptor-mediated bradycardia with a consequent reduction in maternal cardiac output. Although α agonist drugs are the most appropriate agents to treat or prevent hypotension following spinal anaesthesia, those with a small amount of β agonist activity may have the best profile (noradrenaline (norepinephrine) and metaraminol. Phenylephrine is currently recommended due to the amount of supporting data.Noradrenaline is the primary catecholamine released by postganglionic adrenergic nerves. It is a potent α adrenergic agonist, with comparatively modest β agonist activity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NEP group | Active Comparator | Norepinephrine infusion of 0.025 µg/kg/min and 6 µg bolus will be used if BP is reduced 20 % below baseline. |
|
| PHE group | Placebo Comparator | Phenylephrine will be started at 25µg/min immediately after the intrathecal local anaesthetic injection and titrated according to blood pressure and pulse rate. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Norepinephrine | Drug | prophylaxis for hypotension |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of hypotensive episodes. | Hypotension is defined as <80% of baseline or systolic blood pressure (SBP) <100 mmHg. | 15-20 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of maternal bradycardia. | Bradycardia is defined as heart rate (HR) < 50 beats/min | 15-20 minutes |
| Incidence of reactive hypertension | defined as >120% of baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| Fetal outcome | APGAR score | at 1, 5 and 8 minutes |
| mixed blood gas | Umbilical artery and vein blood gas | 1 minute after delivery |
Inclusion Criteria:
Exclusion Criteria:
Patient refusal either to study enrollment or to spinal anesthesia.
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed M. Abdellatif, M.D. | Assiut University | Study Director |
| Shimaa A. Husien, M.D. | Assiut University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assiut University | Asyut | 71515 | Egypt |
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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 | standerd prophylaxis for hypotension |
|
|
| 20 minutes |
| nausea and vomiting | Incidence of nausea and vomiting attacks. | 20 minutes |
| Total dose of vasopressor | Total dose of vasopressor used. | 20 minutes |
| Admission to neonatal ICU (NICU) | the need for NICU admission | first 24 hours 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 |