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临床试验/NCT07389798
NCT07389798已完成不适用

Different Bispectral Index Guided Remimazolam Total Intravenous Anesthesia-flumazenil Antagonism in Short-duration Ear Nose Throat Surgeries: A Retrospective Cohort Study

Tongji Hospital1 个研究点 分布在 1 个国家目标入组 511 人开始时间: 2026年3月9日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
511
试验地点
1
主要终点
Incidence of intraoperative awareness

研究概览

简要总结

This study plans to categorize patients who underwent short-duration ENT surgeries with remimazolam TIVA combined with flumazenil antagonism based on whether their intraoperative BIS values were maintained below 60.

详细描述

This study plans to categorize patients who underwent short-duration ENT surgeries with remimazolam TIVA combined with flumazenil antagonism into two groups based on whether their intraoperative BIS values were maintained below 60. It aims to compare the differences in postoperative recovery quality between the groups, thereby providing evidence-based support for determining the optimal BIS target range during remimazolam TIVA.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-65 years
  • ASA I-III
  • Underwent short-duration ENT surgery
  • Underwent remimazolam TIVA combined with flumazenil antagonism.
  • Continuous intraoperative BIS monitoring

排除标准

  • Comorbid severe underlying diseases
  • Intraoperative BIS data were missing or incompletely recorded
  • Severe lack of medical records

研究组 & 干预措施

AB group

Intraoperative BIS values ≤60

HB group

Intraoperative BIS values >60

结局指标

主要结局

Incidence of intraoperative awareness

时间窗: 2hours

Modified Brice Interview From the start of surgery to the end of surgery

次要结局

  • Incidence of secondary sedation(1 day)
  • heart rate(2 hours)
  • usage of vasoactive drugs(2 hours)
  • Drug doses(2 hours)
  • Awakening time(1 hours)
  • PACU stay(1 hours)
  • mean arterial pressure(2 hours)

研究者

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

aijun xu

Professor

Tongji Hospital

研究点 (1)

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