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临床试验/NCT02585570
NCT02585570已完成不适用

Effect of Phenylephrine Infusion for Preventing Hypotension During Shoulder Arthroscopic Surgery in the Beach Chair Position

Inje University1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2015年10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
已完成
入组人数
66
试验地点
1
主要终点
Incidence of hypotension

研究概览

简要总结

The purpose of this study is to determine whether phenylephrine infusion are effective in the prevention of hypotension after changing position to beach chair position during general anesthesia for shoulder arthroscopic surgery.

Investigators hypothesized that by increasing arterial blood pressure with phenylephrine infusion, incidence of hypotension would be decreased.

详细描述

The beach chair position is associated with hypotension, risk of cerebral hypoperfusion, and cerebral injury. Sixty-six patients undergoing elective shoulder arthroscopic surgery are randomized to receive either phenylephrine low dose (0.5 mcg/kg/hr), phenylephrine high dose (1.0 mcg/kg/min), or normal saline 5 minute before being placed in the beach chair position.

General anesthesia is induced with propofol, remifentanil and rocuronium (0.6 mg/kg) and the trachea intubated. Anesthesia is maintained with sevoflurane and remifentanil targeting for a BIS value 40-60. After hemodynamic stabilization, patients received on infusion of either phenylephrine high dose (1.0 mcg/kg/min), phenylephrine low dose (0.5 mcg/kg/hr) or normal saline 5 minute before being placed in the beach chair position. Following 15 minutes of infusion study drugs, measurements of mean arterial blood pressure and cardiac function (stroke volume variation, stroke volume index, and cardiac index) using Vigileo/Flotrac system were made.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • shoulder arthroscopic surgery undergone beach chair position

排除标准

  • History of cerebrovascular event,
  • significant cardiac disease (New York Heart Association symptoms class ≥ 3)
  • uncontrolled hypertensive patients.
  • American society of anesthesiologist class 4,5

研究组 & 干预措施

Low dose phenylephrine

Experimental

phenylephrine 0.5 mcg/kg/min

干预措施: Phenylephrine (Drug)

High dose phenylephrine

Experimental

phenylephrine 1.0 mcg/kg/min .

干预措施: Phenylephrine (Drug)

结局指标

主要结局

Incidence of hypotension

时间窗: 30 minutes

After being beach chair position during shoulder arthroscopic surgery. We measure the incidence of hypotension with invasive blood pressure (Arterial line catheterization).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ki Hwa Lee

Assistant professor

Inje University

研究点 (1)

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