Phenylephrine Dose and Mode of Administration for Spinal Anesthesia Induced Hypotension

Wake Forest University (WFU)

Status: Withdrawn

Conditions: Spinal Anesthetics Causing Adverse Effects in Therapeutic Use; Complications; Cesarean Section

Treatments: Drug: Phenylephrine

Study type: Interventional

Funder types: Other

Identifiers

NCT02101047

IRB 26872

Details and patient eligibility

About

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.

Full description

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.

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• scheduled for cesarean delivery age >/=18 years of age >/= 37 weeks EGA ASA status I-III

Exclusion criteria

• allergy to medications used in the study non-English speaking

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 3 patient groups

phenylephrine 50mcg bolus

Experimental group

Description:

Phenylephrine 50 mcg bolus dosing with continuous placebo infusion

Treatment:

Drug: Phenylephrine

Phenylephrine 100 mcg bolus

Experimental group

Description:

Phenylephrine 100 mcg bolus dosing wtih continuous placebo infusion.

Treatment:

Drug: Phenylephrine

Phenylephrine continuous infusion 100mcg/min

Experimental group

Description:

Continuous phenylephrine infusion of 100 mcg/min with placebo bolus dosing.

Treatment:

Drug: Phenylephrine