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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, United States
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.
Time frame: 0-90 minutes
provider intervention
number of provider intervention to treat abnormal hemodynamics
Time frame: 0-90 minutes
vasopressor requirement
total amount of vasopressor or equivalent required
Time frame: 0-90 minutes
Emetic symptoms
emetic symptoms - magnitude and/or incidence
Time frame: 0-90 minutes
hypertension
incidence and magnitude
Time frame: 0-90 minutes
hypotension
incidence and magnitude
Time frame: 0-90 minutes
bradycardia
incidence and magnitude
Time frame: 0-90 minutes
Anesthetic time
Time frame: up to 120 minutes
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