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
First author：Sining Xie
Corresponding author：Ruquan Han
essential_information
- Person in charge：Sining Xie
- Data Sources： OTHERS
- Number of papers：OTHERS20230103
- Published time：2023-05-30
2023-05-30
Published articles
Journal：BMJ Open
Publication type: Clinical Trial
IF(IF): 3.006
PMID: 37253497 Link To Pubmed Full text Download
Background And Purpose
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.
Method
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.
Conclusion
None.
Main results
None.