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Norepinephrine has been recently introduced as a prophylactic vasopressor during Cesarean delivery with promising results ; However, the optimum dose for efficient prophylaxis with the least side effects is not known. In this study, we will compare three doses (0.05, 0.1, 0.15 mcg/Kg/min) of norepinephrine for prophylaxis against Post-Spinal hypotension during cesarean delivery.
Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery (CD). Using vasopressors have been considered a gold standard for prevention of post-spinal hypotension (PSH) during CD.
Norepinephrine (NE) is a potent vasopressor characterized by both α adrenergic agonistic activity in addition to a weak β adrenergic agonistic activity; thus, NE is considered a vasopressor with minimal cardiac depressant effect; these pharmacological properties would make NE an attractive alternative to phenylephrine and ephedrine (the most commonly used vasopressors in obstetric anesthesia).
Norepinephrine has been recently introduced as a prophylactic vasopressor during CD with promising results; However, the optimum dose for efficient prophylaxis with the least side effects is not known.
In this study, we will compare three doses (0.05, 0.1, 0.15 mcg/Kg/min) of norepinephrine for prophylaxis against PSH during CD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| - 0.05 mcg /Kg/min group | Experimental | will receive norepinephrine 0.05 mcg /Kg/min after spinal anesthesia by bupivacaine till five-minutes after delivery of the fetus |
|
| - 0.1 mcg /Kg/min group | Experimental | will receive norepinephrine 0.1 mcg /Kg/min after spinal anesthesia by bupivacaine till five-minutes after delivery of the fetus |
|
| - 0.15 mcg /Kg/min group | Experimental | will receive norepinephrine 0.15 mcg /Kg/min after spinal anesthesia by bupivacaine till five-minutes after delivery of the fetus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Norepinephrine 0.05 mcg /Kg/min | Drug | Norepinephrine infusion by rate of 0.05 mcg /Kg/min after spinal anesthesia |
|
| Measure | Description | Time Frame |
|---|---|---|
| incidence of postspinal hypotension | The number of patients who develop hypotension (defined as decreased SBP less than 80% of the baseline reading during the period from intrathecal injection till delivery of the fetus) after spinal block divided by the total number in the group | 30 minutes after spinal anesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| heart rate | heart rate after spinal anesthesia measured in beat per minute | 90 minutes after spinal anesthesia |
| vomiting | incidence of vomiting after spinal anesthesia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmed Mukhtar, Professor | Head of research committee section in anesthesia department | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University | Cairo | Egypt |
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| ID | Term |
|---|---|
| D009638 | Norepinephrine |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Norepinephrine 0.1 mcg /Kg/min | Drug | Norepinephrine infusion by rate of 0.05 mcg /Kg/min after spinal anesthesia |
|
|
| Norepinephrine 0.15 mcg /Kg/min | Drug | Norepinephrine infusion by rate of 0.05 mcg /Kg/min after spinal anesthesia |
|
|
| Bupivacaine | Drug | 10 mg Bupivacaine intra-thecal for spinal anesthesia |
|
|
| 120 minutes after spinal anesthesia |
| nausea | incidence of nausea after spinal anesthesia | 120 minutes after spinal anesthesia |
| ephedrine consumption | total amount of ephedrine consumed after spinal anesthesia | 60 minutes after spinal anesthesia |
| Atropine consumption | total amount of atropine consumed after spinal anesthesia | 60 minutes after spinal anesthesia |
| APGAR score | APGAR score of the delivered fetus | 10 minutes after delivery |
| incidence of severe postspinal hypotension | The number of patients who develop hypotension (defined as decreased SBP less than 60% of the baseline reading during the period from intrathecal injection till delivery of the fetus) after spinal block divided by the total number in the group | 30 minutes after spinal anesthesia |
| arterial blood pressure | arterial blood pressure after spinal anesthesia measured in mmHg | 90 minutes after spinal anesthesia |
| 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 |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |