国家神经系统疾病临床医学研究中心数据管理与共享系统

Data Management And Sharing System of China National Clinical Research Center for Neurological Diseases

Choice of anaesthesia in microelectrode recording-guided deep-brain stimulation for Parkinson's disease (CHAMPION): study protocol for a single-centre, open-label, non-inferiority randomised controlled trial

第一作者:Sining Xie

通讯作者:Ruquan Han

Parkinson

基本信息

  • 负责人:Sining Xie
  • 数据来源: OTHERS
  • 论文编号:OTHERS20230103
  • 发表时间:2023-05-30

2023-05-30

已发表文章

发表杂志:BMJ Open

发表类型: Clinical Trial

影响因子(IF): 3.006

PMID: 37253497 Pubmed原文链接 全文下载

主要研究背景及目的

Deep brain stimulation (DBS) implantation under general anaesthesia (GA) has been applied to patients with Parkinson's disease (PD) with severe comorbidities or disabling off-medication symptoms. However, general anaesthetics may affect intraoperative microelectrode recording (MER) to varying degrees. At present, there are few studies on the effects of sedatives or general anaesthetics on multiunit activity characteristics performed by MER in patients with PD during DBS. Therefore, the effect of the choice of anaesthesia on MER remains unclear.

方法

This is a prospective randomised controlled, non-inferiority study that will be carried out at Beijing Tiantan Hospital, Capital Medical University. Patients undergoing elective bilateral subthalamic nucleus (STN)-DBS will be enrolled after careful screening for eligibility. One hundred and eighty-eight patients will be randomised to receive either conscious sedation (CS) or GA at a 1:1 ratio. The primary outcome is the proportion of high normalised root mean square (NRMS) recorded by the MER signal.

结论

None.

主要结果

None.