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临床试验/NCT06091904
NCT06091904招募中不适用

Effects of Sufentanil on the Intraoperative Hemodynamic Parameters in Patients Undergoing Extracranial-intracranial Bypass Surgery: a Prospective Randomized Controlled Trial

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2023年11月24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
招募中
入组人数
92
试验地点
1
主要终点
Intraoperative hypotension

研究概览

简要总结

This study is a randomized, controlled trial. A total of 92 patients will be randomized to receive sufentanil or remifentanil during extracranial-intracranial bypass surgery.

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
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • Patients who undergo elective extracranial-intracranial bypass surgery
  • American Society of Anesthesiologists grade 1,2,3
  • Age > 18 years old

排除标准

  • Refuse to participate to the study
  • American Society of Anesthesiologists grade 4
  • Body Mass Index < 18.5 kg/m2 or > 35 kg/m2
  • Allergic history of opioid
  • MAO Inhibitor user
  • Severe respiratory insufficiency

研究组 & 干预措施

sufentanil group

Experimental

sufentanil is administered for analgesic during general anesthesia

干预措施: Sufentanil (Drug)

remifentanil group

Active Comparator

remifentanil is administered for analgesic during general anesthesia

干预措施: Remifentanil (Drug)

结局指标

主要结局

Intraoperative hypotension

时间窗: During surgery

MAP \< 80 mmHg

次要结局

  • Incidence of tachycardia(During surgery)
  • Incidence of bradycardia(During surgery)
  • Minimum systolic blood pressure(During surgery)
  • Inotropic requirements(During surgery)
  • Maximum systolic blood pressure(During surgery)

研究者

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

Chang-Hoon Koo

Assistant professor

Seoul National University Hospital

研究点 (1)

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