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临床试验/NCT02101047
NCT02101047撤回不适用

Correlation and Effects on Cardiac Output With Intermittent Phenylephrine Administration of 50 mcg Versus 100 mcg or 100mcg/Min Prophylactic Infusion for Treatment of Hypotension in Parturients After Receiving Spinal Anesthesia for Cesarean Delivery

Wake Forest University Health Sciences1 个研究点 分布在 1 个国家开始时间: 2015年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Magnitude of cardiac output changes

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

Phenylephrine continuous infusion 100mcg/min

Experimental

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

干预措施: Phenylephrine (Drug)

phenylephrine 50mcg bolus

Experimental

Phenylephrine 50 mcg bolus dosing with continuous placebo infusion

干预措施: Phenylephrine (Drug)

Phenylephrine 100 mcg bolus

Experimental

Phenylephrine 100 mcg bolus dosing wtih continuous placebo infusion.

干预措施: Phenylephrine (Drug)

结局指标

主要结局

Magnitude of cardiac output changes

时间窗: 0-90 minutes

Magnitude of cardiac output reduction for the duration from preoperative baseline from time of spinal anesthesia to delivery of fetus and placenta.

次要结局

  • bradycardia(0-90 minutes)
  • hypotension(0-90 minutes)
  • hypertension(0-90 minutes)
  • Anesthetic time(up to 120 minutes)
  • Emetic symptoms(0-90 minutes)
  • vasopressor requirement(0-90 minutes)
  • provider intervention(0-90 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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