跳至主要内容
临床试验/NCT03343873
NCT03343873招募中不适用

The Effects of Different Anesthetics on Functional Connectivity in Volunteers and Patients With Brain Tumor (ACTION)

Beijing Tiantan Hospital1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2017年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
240
试验地点
1
主要终点
Amplitude of Low Frequency Fluctuations(ALLF)and Regional Homogeneity(ReHo)

研究概览

简要总结

This research is a prospective cohort study. The aim of the study is to determine different levels of sedative mechanism and the effect on brain functional connectivity of midazolam, dexmedetomidine and propofol.

详细描述

This research will include 120 healthy volunteers and 120 brain tumor patients; the participants will be allocated into midazolam, dexmedetomidine and propofol group. Resting and task fMRI will be performed at awake (BIS>90), mild sedation (BIS 80-85), moderate sedation (BIS 65-75), deep sedation (BIS 45-55) and recovery states (BIS >90). The primary outcome of our study is the effect of different levels of sedation for brain network connection. The secondary outcomes are the effect of different levels of sedation for default, executive control, sensory and motor networks and their subnetwork connectivity; the sedation state, circulatory and respiratory parameters of the participants, and the adverse events.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

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

入选标准

  • Male, 18 ~ 65 years old
  • Healthy Volunteer / Brain Tumor Patients
  • Senior high school and above
  • Sign informed consent

排除标准

  • In vivo implant MRI check taboo
  • Cardiopulmonary liver and kidney and other systemic complications
  • History of major surgical anesthesia
  • Abuse of drugs, alcoholism history
  • Test drug allergy history
  • Claustrophobia

研究组 & 干预措施

dexmedetomidine

Experimental

dexmedetomidine sensation group

干预措施: Dexmedetomidine (Drug)

Midarolam

Experimental

midarolam sensation group

干预措施: Midazolam (Drug)

Propofol

Experimental

propofol sensation group

干预措施: Propofol (Drug)

结局指标

主要结局

Amplitude of Low Frequency Fluctuations(ALLF)and Regional Homogeneity(ReHo)

时间窗: 30mins after administration

The differences of amplitude of low frequency fluctuations (ALFF/Low Frequency Amplitude) and regional homogeneity(ReHo) in brain voxel - wise under anesthetic sedations.

次要结局

未报告次要终点

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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