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
Introduction 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 v...
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| Format: | Article |
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BMJ Publishing Group
2023-05-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/5/e071726.full |
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| author | Anxin Wang Lin Shi Liang Chen Jianguo Zhang Ruquan Han Wei Xiong Sining Xie Xiangjiahui Li Yuanyuan Tong Wanning Yang |
| author_facet | Anxin Wang Lin Shi Liang Chen Jianguo Zhang Ruquan Han Wei Xiong Sining Xie Xiangjiahui Li Yuanyuan Tong Wanning Yang |
| author_sort | Anxin Wang |
| collection | DOAJ |
| description | Introduction 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.Ethics and dissemination 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.Trial registration number NCT05550714. |
| first_indexed | 2024-03-13T08:36:52Z |
| format | Article |
| id | doaj.art-3c259873fb2b432ab9e8fd299cfcdf62 |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-03-13T08:36:52Z |
| publishDate | 2023-05-01 |
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| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-3c259873fb2b432ab9e8fd299cfcdf622023-05-30T21:30:06ZengBMJ Publishing GroupBMJ Open2044-60552023-05-0113510.1136/bmjopen-2023-071726Choice 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 trialAnxin Wang0Lin Shi1Liang Chen2Jianguo Zhang3Ruquan Han4Wei Xiong5Sining Xie6Xiangjiahui Li7Yuanyuan Tong8Wanning Yang9Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, ChinaDepartment of Neurosurgery, Beijing Neurosurgical Institute, Beijing, ChinaDepartment of Immunology, AbbVie Inc, North Chicago, Illinois, USADepartment of Neurosurgery, Beijing Neurosurgical Institute, Beijing, ChinaDepartment of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, ChinaFirst Affiliated Hospital, Sun Yat-sen University, Guangzhou, ChinaDepartment of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, ChinaDepartment of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, ChinaDepartment of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, ChinaDepartment of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, ChinaIntroduction 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.Ethics and dissemination 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.Trial registration number NCT05550714.https://bmjopen.bmj.com/content/13/5/e071726.full |
| spellingShingle | Anxin Wang Lin Shi Liang Chen Jianguo Zhang Ruquan Han Wei Xiong Sining Xie Xiangjiahui Li Yuanyuan Tong Wanning Yang 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 BMJ Open |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/13/5/e071726.full |
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