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临床试验/NCT05164146
NCT05164146已完成不适用

The Comparison of Hypotension Incidence Between Remimazolam and Propofol in Hypertensive Patients Undergoing Neurosurgery

Yonsei University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年2月23日最近更新:
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
100
试验地点
1
主要终点
incidence of hypotension events

研究概览

简要总结

This study aims to find an excellent drug in terms of hemodynamic stability when comparing the propofol and remifentanil with the combined use of remimazolam and remifentanil. When the mean blood pressure falls by 20% or more from the baseline mean blood pressure, it is considered hypotension, and a vasopressor such as ephedrine, phenylephrine, or norpin is used to control the blood pressure to within 20% of the baseline blood pressure. If the blood pressure increases by 20% or more above the baseline mean blood pressure, nicardipine infusion or remimazolam, propofol or remifentanil should be increased to control the blood pressure.

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
Single (Participant)

入排标准

年龄范围
19 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • hypertension
  • patients undergoing neurosurgery
  • 19-75 year-old patients

排除标准

  • Patients admitted on the day of surgery
  • cardiac disease
  • liver failure or liver cirrhosis
  • increased intracranial pressure(IICP)
  • mental change

研究组 & 干预措施

propofol group

Active Comparator

During the induction, propofol was controlled according to sedline (Psi target 40)

干预措施: propofol (Drug)

remimazolam group

Experimental

During induction, remimazolam dose was controlled according to sedline (Psi target 40)

干预措施: remimazolam (Drug)

结局指标

主要结局

incidence of hypotension events

时间窗: procedure (during induction before the surgery)

Hypotension is considered when the mean blood pressure is 20% or more below the baseline mean blood pressure.

次要结局

  • blood pressure(procedure (during induction before the surgery))
  • heart rate(procedure (during induction before the surgery))
  • sedline psi(procedure (during induction before the surgery))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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