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Comparison will be conducted between continuous variable infusions of both drugs (Phenylephrine and Norepinephrine) with starting doses of 0.75 mcg/Kg/min and 0.1 mcg/Kg/min respectively for prophylaxis against Post-spinal hypotension during cesarean delivery.
Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery (CD). Many vasopressors have been used for prevention of post-spinal hypotension (PSH) during CD; however, the optimum protocol for prophylaxis is not established yet. Phenylephrine (PE) is a popular vasopressor used in obstetric anesthesia; however, its use is limited by its marked cardiac depressant nature. 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 PE. In this study, we will compare continuous variable infusion of both drugs (PE and NE) with doses of 0.75 mcg/Kg/min and 0.1 mcg/Kg/min respectively for prophylaxis against PSH during CD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phenylephrine | Active Comparator | Will receive spinal anesthesia using Bupivacaine. Then, phenylephrine infusion by a starting rate of 0.75 mcg/Kg/min. The rate will be then adjusted according to the patient blood pressure |
|
| Norepinephrine | Experimental | Will receive spinal anesthesia using Bupivacaine. Then, norepinephrine infusion by a starting rate of 0.1 mcg/Kg/min. The rate will be then adjusted according to the patient blood pressure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phenylephrine | Drug | Phenylephrine variable infusion with a starting rate of 0.75 mcg/Kg/min. |
|
| Measure | Description | Time Frame |
|---|---|---|
| incidence of post-spinal anesthesia hypotension | Defined as the percentage of patients with decreased systolic blood pressure less than 80% of the baseline reading | 30 minutes after spinal anesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of severe post-spinal anesthesia hypotension | Defined as the percentage of patients with decreased systolic blood pressure less than 60% of the baseline reading | 30 minutes after spinal anesthesia |
| incidence of severe delivery hypotension |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed Hasanin, Professor | Contact | +201095076954 | ahmedmohamedhasanin@gmail.com |
| 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 | Recruiting | Cairo | Egypt |
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| ID | Term |
|---|---|
| D010656 | Phenylephrine |
| D009638 | Norepinephrine |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Norepinephrine | Drug | Norepinephrine variable infusion with a starting rate of 0.1 mcg/Kg/min. |
|
|
| Bupivacaine | Drug | Bupivacaine will be injected in the subarachnoid space with a dose of 10 mg |
|
|
Defined as the percentage of patients with decreased systolic blood pressure less than 80% of the baseline reading
| 10 minutes after delivery |
| systolic blood pressure | systolic blood pressure measured in mmHg | 2 hours after subarachnoid block |
| diastolic blood pressure | diastolic blood pressure measured in mmHg | 2 hours after subarachnoid block |
| heart rate | number of heart beats per minute | 2 hours after subarachnoid block |
| APGAR score | APGAR score of the fetus | 10 minutes after delivery |
| incidence of reactive hypertension | Defined as the percentage of patients with increased systolic blood pressure more than 80% of the baseline reading | 2 hours 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 |