Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
BMJ Open. 2023 May 30;13(5):e071726. doi: 10.1136/bmjopen-2023-071726.
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.
METHODS/DESIGN: 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.
The study was approved by the Ethics Committee of Beijing Tiantan Hospital of Capital Medical University (KY2022-147-02). Negative study results will indicate that GA using desflurane has a non-inferior effect on MER during STN-DBS compared with CS. The results of this clinical trial will be presented at national or international conferences and submitted to a peer-reviewed journal.
NCT05550714.
在全身麻醉（GA）下植入深部脑刺激（DBS）已应用于患有严重合并症或药物治疗无效的帕金森病（PD）患者。然而，全身麻醉剂可能会对术中微电极记录（MER）产生不同程度的影响。目前，关于镇静剂或全身麻醉对 DBS 期间 PD 患者 MER 多单位活动特征的影响的研究较少。因此，麻醉选择对 MER 的影响尚不清楚。
方法/设计：这是一项在北京天坛医院首都医科大学进行的前瞻性随机对照非劣效性研究。经过仔细筛选符合条件的患者将被纳入接受选择性双侧丘脑底核（STN）-DBS 手术的患者。188 名患者将按照 1:1 的比例随机接受清醒镇静（CS）或 GA。主要结局是 MER 信号记录的高正常化均方根（NRMS）的比例。
该研究得到了首都医科大学附属北京天坛医院伦理委员会的批准（KY2022-147-02）。阴性研究结果表明，与 CS 相比，使用地氟醚的 GA 在 STN-DBS 期间对 MER 的影响无差异。本临床试验的结果将在国内或国际会议上展示，并提交给同行评议的期刊。
NCT05550714。
