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The investigators will compare variable infusion of phenylephrine (at a starting rate of 0.75 mcg/Kg/min) with fixed rate (0.75 mcg/Kg/min which will stop of reactive hypertension occurred) and single shot (1.5 mcg/Kg) phenylephrine.
Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery (CD). Phenylephrine (PE) is the most popular vasopressor for prevention of post-spinal hypotension (PSH) during CD; however, the most appropriate protocol for PE administration is still unknown. The most common PE protocols used for prophylaxis against PSH are: single shot, fixed infusion, and variable infusion. A recent study reported that a dose of 1.5 mcg/Kg is the most suitable single-shot dose for prophylaxis. Another randomized controlled trial compared four doses of PE infusion and reported that 25 mcg/Kg/min and 50 mcg/Kg/min doses were the best doses for fixed infusion with accepted incidence of both PSH as well as reactive hypertension. Using variable infusion rate of PE had been recently introduced in another study with a starting dose of 0.75 mcg/Kg/min. The variable rate infusion showed very good results regarding PSH. In this study, the investigators will compare variable infusion of PE (at a starting rate of 0.75 mcg/Kg/min) with fixed rate (0.75 mcg/Kg/min which will stop if reactive hypertension occurred) and single shot protocol (1.5 mcg/Kg).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single shot | Experimental | Spinal anesthesia will be performed using intrathecal bupivacaine. Then, a single shot phenylephrine (1.5 ug/Kg) will be administered. |
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| Fixed infusion | Active Comparator | Spinal anesthesia will be performed using intrathecal bupivacaine. Then, fixed infusion phenylephrine will be administered at a dose of (0.75 mcg/Kg/min). the infusion will stop if reactive hypertension occurred. |
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| Variable infusion | Active Comparator | Spinal anesthesia will be performed using intrathecal bupivacaine. Then, variable infusion phenylephrine will be administered at a starting dose of (0.75 mcg/Kg/min). the infusion will be titrated according to blood pressure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single shot phenylephrine | Drug | A single shot of phenylephrine (1.5 mcg/Kg) will be administrated intravenously. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Post-spinal anesthesia hypotension | Defined as percentage of patients with decreased systolic blood pressure less than 80% of the baseline reading during the period from intrathecal injection to delivery of the fetus | 30 minutes after spinal anesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of severe Post-spinal anesthesia hypotension | Defined as percentage of patients with decreased systolic blood pressure less than 60% of the baseline reading during the period from intrathecal injection to delivery of the fetus. | 30 minutes after spinal anesthesia |
| Incidence of reactive hypertension |
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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 |
|---|---|
| D010656 | Phenylephrine |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Fixed infusion phenylephrine. | Drug | Fixed infusion of phenylephrine will be administrated at a rate of 0.75 mcg/Kg/min |
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| Variable infusion phenylephrine. | Drug | Variable infusion of phenylephrine will be administrated at a starting rate of 0.75 mcg/Kg/min. |
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| Bupivacaine | Drug | Bupivacaine will be administrated in the subarachnoid space for spinal anesthesia. |
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Defined as percentage of patients with increased systolic blood pressure more than 80% of the baseline reading during the period from intrathecal injection to delivery of the fetus. |
| 2 hours after spinal anesthesia |
| Systolic blood pressure | Systolic blood pressure measured in mmHg | 2 hours after spinal anesthesia |
| Diastolic blood pressure | Diastolic blood pressure measured in mmHg | 2 hours after spinal anesthesia |
| Heart rate | number of heart beats per minute | 2 hours after spinal anesthesia |
| APGAR score | APGAR score of the fetus | 10 minutes after delivery |
| umbilical arterial PH | the PH in umbilical arterial blood | 10 minutes after delivery |
| umbilical arterial Pco2 | umbilical arterial Pco2 measured in mmHg | 10 minutes after delivery |
| D000588 |
| Amines |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |