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临床试验/NCT04725032
NCT04725032招募中不适用

Comparison of the Effects of Total Intravenous Anesthesia and Balanced General Anesthesia on Flash Visual Evoked Potential Monitoring During Sellar Tumors Resection

Beijing Tiantan Hospital1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2021年1月25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
发起方
入组人数
84
试验地点
1
主要终点
N2 amplitudes of FVEPs

研究概览

简要总结

Intraoperative flash visual evoked potentials (FVEPs) could monitor visual function during neurosurgery. There are fewer reports comparing the effects of sevoflurane-propofol balanced anesthesia and propofol-based total intravenous anesthesia under comparable bispectral index (BIS) levels on the amplitude and latency of flash visual evoked potentials (FVEPs) for sellar or parasellar tumors resection neurosurgeries.

详细描述

The overall incidence rate of sellar tumors is 10-20% of brain tumors. Most of the initial symptoms of this tumor are visual or visual impairment. One of the primary complications of these operations is visual impairment, which directly relates to the quality of patients' life. Flash visual evoked potentials (FVEPs) is an important means of intraoperative visual function evaluation under general anesthesia. Intraoperative visual function damage can be avoided or reduced by observing the changing of FVEPs waves to guide the choice of surgical path.

However, since the diversity of anesthetic drugs and methods, there is still a great uncertainty impact on FVEPs, which will interfere with the interpretation and judgment of surgeons and neuroelectrophysiological physicians respect to the changes of FVEPs amplitude and latency, and further affect the operation decision-making. Therefore, it is urgent to establish a perfect anesthesia method for intraoperative monitoring of FVEPs. Although total intravenous anesthesia has been widely accepted for FVEPs monitoring, there are still some limitations, such as the possibility of intraoperative body movement and cough due to the restriction of muscle relaxant use under electrophysiological monitoring, as well as the depression on FVEPs of high maintained dosage under total intravenous anesthesia. The purpose of this study was to investigate the feasibility of FVEPs monitoring during endoscopic sellar tumor resection under combined intravenous anesthesia compared with total intravenous anesthesia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Double (Participant, Outcomes Assessor)

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;
  • Elective sellar or parasellar tumors resection;
  • Informed written consent

排除标准

  • Preoperative visual acuity<0.3;
  • BMI>30kg/cm2;
  • Uncontrolled hypertension, diabetes or cardiac diseases;
  • Preoperative cognitive disorders;
  • Sedatives, alcohol or analgesic addiction history;
  • Allergy to drugs of this study or contact allergy to Silicone products

研究组 & 干预措施

sevoflurane-propofol balanced anesthesia

Experimental

干预措施: Sevoflurane (Drug)

propofol-based total intravenous anesthesia

Active Comparator

干预措施: Propofol (Drug)

结局指标

主要结局

N2 amplitudes of FVEPs

时间窗: 90min after anesthesia induction

N145-P100 of FVEPs wave

次要结局

  • N2 amplitudes of FVEPs(30 and 60 after anesthesia induction)
  • P100 latencies of FVEPs(30, 60 and 90min after anesthesia induction)
  • The visual acuity(The day before surgery, and one day after operation.)
  • The visual field(The day before surgery, and one day after operation.)

研究者

发起方
Beijing Tiantan Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ruquan Han

Professor

Beijing Tiantan Hospital

研究点 (1)

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