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three doses (0.025 mcg/Kg/min, 0.050 mcg/Kg/min, and 0.075 mcg/Kg/min) of norepinephrine will be compared for prophylaxis against Post-spinal anesthesia 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 agonist activity in addition to a weak β adrenergic agonist 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, three doses (0.025, 0.050, 0.075 mcg/Kg/min) of norepinephrine will be compared for prophylaxis against PSH during CD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.025 mcg /Kg/min group | Experimental | The patients will receive spinal anesthesia through 10 mg Bupivacaine, then start norepinephrine bitartrate infusion (0.05 mcg/Kg/min) equivalent to norepinephrine infusion (0.025 mcg/Kg/min). |
|
| 0.050 mcg/Kg/min group | Experimental | The patients will receive spinal anesthesia through 10 mg Bupivacaine, then start norepinephrine bitartrate infusion (0.1 mcg/Kg/min) equivalent to norepinephrine infusion (0.050 mcg/Kg/min). |
|
| 0.075 mcg/Kg/min group | Experimental | The patients will receive spinal anesthesia through 10 mg Bupivacaine, then start norepinephrine bitartrate infusion (0.15 mcg/Kg/min) equivalent to norepinephrine infusion (0.075 mcg/Kg/min) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| norepinephrine infusion (0.025 mcg/Kg/min) | Drug | The patients will receive a bolus of 5 mcg norepinephrine followed by norepinephrine bitartrate infusion of (0.05 mcg/Kg/min) equivalent to norepinephrine base of (0.025 mcg/Kg/min) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
|---|---|---|
| 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 |
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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 |
|---|---|
| D002045 | Bupivacaine |
| D000775 | Anesthesia, Spinal |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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|
| norepinephrine infusion (0.050 mcg/Kg/min) | Drug | The patients will receive a bolus of 5 mcg norepinephrine followed by norepinephrine infusion of (0.1 mcg/Kg/min) equivalent to norepinephrine base of (0.050 mcg/Kg/min) |
|
|
| norepinephrine infusion (0.075 mcg/Kg/min) | Drug | The patients will receive a bolus of 5 mcg norepinephrine followed by norepinephrine infusion of (0.15 mcg/Kg/min) equivalent to norepinephrine base of (0.075 mcg/Kg/min). |
|
|
| Bupivacaine | Drug | The patient will receive spinal anesthesia using Bupivacaine (10 mg). |
|
|
| Post-delivery hypotension |
number of patients who develop hypotension (defined as decreased SBP less than 80% of the baseline reading after delivery of the fetus and starting oxytocin infusion) |
| 10 minutes after delivery |
| systolic blood pressure | systolic blood pressure measured in mmHg | 60 minutes after spinal block |
| diastolic blood pressure | diastolic blood pressure measured in mmHg | 60 minutes after spinal block |
| heart rate | heart rate measured in beats per minute | 60 minutes after spinal block |
| intraoperative hypertension | number of patients who develop intraoperive hypertension (defined as increased systolic blood pressure by more than 20% of the baseline reading) divided by the total number of patients in the group | 60 minutes after spinal block |
| incidence of nausea and vomiting | number of patients who develop nausea and vomiting divided by the total number of patients in the group | 60 minutes after spinal block |
| ephedrine consumption | total amount of ephedrine consumed during the operation (measured in milligrams) | 60 minutes after spinal block |
| Atropine consumption | total amount of atropine consumed during the operation (measured in milligrams) | 60 minutes after spinal block |
| APGAR score | APGAR score for detection of the well being of the fetus | 1 minute after delivery |
| APGAR score | APGAR score for detection of the well being of the fetus | 10 minutes after delivery |
| D000588 |
| Amines |
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |