Choice of Anesthesia in Microelectrode Recording Guided Deep Brain Stimulation for Parkinson's Disease (CHAMPION)：A Randomized Controlled, Non-Inferiority Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 188
- 试验地点
- 1
- 主要终点
- The proportion of high-normalized root mean square (high-NRMS) recorded by the MER signal (with the average NRMS recorded by MER after entering the STN greater than 2.0).
研究概览
简要总结
Subthalamic nucleus (STN)-deep brain stimulation (DBS) under general anesthesia has been applied to PD patients who cannot tolerate awake surgery, but general anesthesia will affect the electrical signal in microelectrode recording (MER) to some degree. This study is a prospective randomized controlled, noninferiority study, open label, endpoint outcome evaluator blinded, two-arm study. Parkinson's disease patients undergoing STN-DBS are randomly divided into a conscious sedation group (dexmedetomidine) and a general anesthesia group (desflurane). Normalized root mean square (NRMS) is used to compare the difference of neuronal activity between the two groups. The primary outcome is the percentage of high NRMS recorded by the MER signal (with the average NRMS recorded by MER after entering the STN greater than 2.0). The secondary outcomes are the NRMS, length of the STN, number of MER tracks, and differences in clinical outcomes 6 months after the operation.
详细描述
STN-DBS under general anesthesia has been applied to PD patients who cannot tolerate awake surgery, but general anesthesia will affect the electrical signal in microelectrode recording (MER) to some degree. At present, there are some studies on the effects of desflurane on neuronal signal amplitude and discharge characteristics during STN-DBS in PD patients but there is no definite conclusion.
This study compares the influence of MER mapping during STN-DBS and the differences in postoperative clinical outcomes between desflurane general anesthesia and conscious sedation anesthesia to explore alternative anesthesia for DBS in PD patients who cannot tolerate local anesthesia or conscious sedation and to provide feasible anesthesia techniques for the application of MER during DBS under general anesthesia.
This study is a prospective randomized controlled, noninferiority study, open label, endpoint outcome evaluator blinded, two-arm study. Parkinson's disease patients undergoing STN-DBS are randomly divided into a conscious sedation group (dexmedetomidine) and a general anesthesia group (desflurane). The primary outcome is the percentage of high NRMS recorded by the MER signal (with the average NRMS recorded by MER after entering the STN greater than 2.0), which is used to compare the differences in neuronal electrical activities between conscious sedation and general anesthesia via desflurane groups. The secondary outcomes are the NRMS, length of the subthalamic nucleus, number of MER tracks, and differences in clinical outcomes 6 months after the operation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.50-80 years old, ASA grade II-III; 2.Bilateral STN-DBS of patients with Parkinson's disease; 3.Signed informed consent.
排除标准
- •Obstructive sleep apnea;
- •BMI > 30kg/m2;
- •Estimated difficult airway;
- •Severe preoperative anxiety;
- •Serious dysfunction of important organs (i.e. heart failure, renal or liver dysfunction)
- •A history of allergy to the anaesthetics.
研究组 & 干预措施
General anesthesia
干预措施: general anesthesia (Drug)
Conscious sedation
干预措施: Conscious sedation (Drug)
结局指标
主要结局
The proportion of high-normalized root mean square (high-NRMS) recorded by the MER signal (with the average NRMS recorded by MER after entering the STN greater than 2.0).
时间窗: 1 day (during MER recording)
We will use the root mean square (RMS) value of the MER sampled signal as the main parameter for evaluating electrode position. RMS values change with the electrode properties and other external drives related to the operating room; therefore, it is crucial to normalize the RMS to comparable values. Thus, each session's RMS in a trajectory is divided by the mean RMS of the first five stable sessions in the same trajectory. This normalized RMS (NRMS) is found to be a good measure as it reflects the relative change in the total power of the signal, which elevates dramatically entering the STN.
次要结局
- Total electrode path times(1 day (during MER recording))
- Firing rates(1 day (during MER recording))
- Beta band (13-30 Hz) oscillations calculated by spectrum analysis(1 day (during MER recording))
- Lengths of STN(mm)(1 day (during MER recording))
- Proportion of intraoperative remedial measures implemented(1 day (during MER recording))
- Quality of life measured with the Parkinson's Disease Quality of Life Questionnaire (PDQ-39)(6 months after STN-DBS)
- The accuracy of the DBS electrode(Within 24 hours after the operation)
- Surgical experience satisfaction 24 hours after the operation and DBS satisfaction 6 months after the operation evaluated by the seven-point Likert scale(24 hours after operation for surgical experience satisfaction and 6 months after STN-DBS for DBS satisfaction)
- NRMS and their stratified proportions in the CS and GA groups(1 day (during MER recording))
- Duration of operation and MER(1 day (during the DBS surgery))
- Clinical efficacy measured with the improvement of the United Parkinson's Disease Rating Scale (UPDRS)-III (conditions: med on/off, stim on/off)(6 months after STN-DBS)
- Cognitive function as measured by the Mini-Mental State Examination (MMSE) and the Montreal Cognitive Assessment (MoCA)(At baseline and 24 hours, 2 days, 3 days and 6 months after the operation)
- Clinical efficacy measured with Levodopa equivalent daily dose (LEDD) reduction(6 months after STN-DBS)
- The incidence of operation-related complications(Up to 6 months after randomization)
- The incidence of anaesthesia-related adverse events(Up to 3 days after randomization)
研究者
Ruquan Han
Director of Anesthesiology Department
Beijing Tiantan Hospital