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Three different regimens of phenylephrine are being evaluated to see if one is superior over the other in the maintenance of cardiac output while keeping normotension and/or treating hypotension experienced when receiving spinal anesthesia for cesarean delivery.
Phenylephrine will be administered in one of 3 regimens: Intermittent bolus of 50 mcg, Intermittent bolus of 100 mcg, or continuous infusion of 100 mcg/min. The infusion will contain either phenylephrine or normal saline (placebo). Subjects who are randomized to receive a bolus dose will receive placebo in the infusion. Subjects who are randomized to receive the phenylephrine infusion will have normal saline (placebo) in the bolus syringe. Baseline blood pressures will be obtained prior to surgery and then maintained using these drugs. Blood pressure and heart rate will be monitored as usual standard of care. Continuous cardiac output and hemodynamic monitoring will be obtained using CNAP (Tm) or similar (equivalent) monitoring device. Blood pressure will be maintained at 90-120% of baseline utilizing infusion and/or bolus with the 3 regimens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| phenylephrine 50mcg bolus | Experimental | Phenylephrine 50 mcg bolus dosing with continuous placebo infusion |
|
| Phenylephrine 100 mcg bolus | Experimental | Phenylephrine 100 mcg bolus dosing wtih continuous placebo infusion. |
|
| Phenylephrine continuous infusion 100mcg/min | Experimental | Continuous phenylephrine infusion of 100 mcg/min with placebo bolus dosing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phenylephrine | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Magnitude of cardiac output changes | Magnitude of cardiac output reduction for the duration from preoperative baseline from time of spinal anesthesia to delivery of fetus and placenta. | 0-90 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| provider intervention | number of provider intervention to treat abnormal hemodynamics | 0-90 minutes |
| vasopressor requirement | total amount of vasopressor or equivalent required |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Pan, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novant Health Forsyth Medical Center | Winston-Salem | North Carolina | 27103 | United States |
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| ID | Term |
|---|---|
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D010656 | Phenylephrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| 0-90 minutes |
| Emetic symptoms | emetic symptoms - magnitude and/or incidence | 0-90 minutes |
| hypertension | incidence and magnitude | 0-90 minutes |
| hypotension | incidence and magnitude | 0-90 minutes |
| bradycardia | incidence and magnitude | 0-90 minutes |
| Anesthetic time | up to 120 minutes |
| D000588 |
| Amines |