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临床试验/NCT00996190
NCT00996190已完成4 期

Study to Determine the Best Regimen for Administration of Phenylephrine During Spinal Anesthesia for Cesarean Delivery, as Determined by Maternal Blood Pressure and Cardiac Output

Samuel Lunenfeld Research Institute, Mount Sinai Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2009年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
The maximum decrease in cardiac output in the pre-delivery period.

研究概览

简要总结

During Cesarean delivery, phenylephrine is used to maintain the patient's blood pressure. Low blood pressure is the most common side effect of the spinal medication used to anesthetize the patient prior to the start of surgery. This low blood pressure can also trigger unpleasant side effects such as nausea, vomiting and low Apgar scores for the baby.

Currently there are 2 methods of phenylephrine administration during Cesarean section. One method is by intermittent bolus and the other is by continuous infusion. It is ideal to have a regimen for phenylephrine administration that maintains blood pressure without compromising cardiac output.

In this study, cardiac output and blood pressure will be measured by transthoracic bioimpedance, which is a new technique of noninvasive continuous cardiac output monitoring.

The hypothesis of this study is that the continuous infusion of phenylephrine will be equally effective in maintaining blood pressure as compared to the intermittent injection, and will induce less hemodynamic changes.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Ability to communicate in English
  • Elective Cesarean Delivery under spinal anesthesia
  • Normal singleton pregnancy beyond 36 weeks gestation
  • ASA physical status I/II
  • Weight 50-100 kg, height 150-180 cm
  • Age over 18 years

排除标准

  • Patient refusal
  • Inability to communicate in English
  • Allergy or hypersensitivity to phenylephrine
  • Preexisting or pregnancy-induced hypertension
  • Cardiovascular or cerebrovascular disease
  • Fetal abnormalities
  • History of diabetes, excluding gestational diabetes
  • Contra-indications for spinal anesthesia

研究组 & 干预措施

Phenylephrine Intermittent Bolus

Active Comparator

Bolus syringe will contain 120 micrograms/mL of phenylephrine. Infusion solution bag will contain placebo (saline solution).

干预措施: Phenylephrine (Drug)

Phenylephrine Continuous Infusion

Active Comparator

Infusion solution bag will contain 120 micrograms/mL of phenylephrine. Bolus syringe will contain placebo (saline solution).

干预措施: Phenylephrine (Drug)

结局指标

主要结局

The maximum decrease in cardiac output in the pre-delivery period.

时间窗: 30 minutes

次要结局

  • Maximum decrease in heart rate in the pre-delivery period.(30 minutes)
  • Incidence of hypotension in the pre-delivery period (BP < 80% baseline)(30 minutes)
  • Incidence of hypertension in the pre-delivery period (BP > 120% baseline)(30 minutes)
  • Incidence of nausea and vomiting in the pre-delivery period(30 minutes)
  • Total dose of phenylephrine in the pre-delivery period(30 minutes)
  • Umbilical artery and vein blood gases(24 hours)

研究者

发起方
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
申办方类型
Other

研究点 (1)

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