UPDRS-III Comparisons of Deep Brain Stimulation for Parkinson's Disease Between Patients Receiving MAC and AAA Anesthesia: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Scores' change of Unified Parkinson's Rating Scale (part III/motor part)
研究概览
简要总结
Compares the patients' scores of UPDRS-III before and six-month after receiving deep brain stimulation for Parkinson's disease under MAC or AAA anesthesia.
详细描述
Compares the patients' scores of UPDRS-III before and six-month after receiving deep brain stimulation for Parkinson's disease under MAC or AAA anesthesia. Besides, the research also compares the adverse events, LED, dosage of anesthetic drugs, wake-up time, surgical time, Hoehn&Yahr, PQD-39, MMSE, MoCA, HAMA, HAMD and patients' satisfaction between the two groups mentioned above.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than 18 years old
- •Diagnosis of primary Parkinson's disease
- •Parkinson's disease-related symptoms remain difficult to control with appropriate anti-parkinsonian medications.
排除标准
- •Refusal to Participate in the research
- •Patients with severe comorbidities such as severe sleep apnea syndrome and metal disorder
- •Previous functional neurosurgery: DBS, thalamic incision, etc.
结局指标
主要结局
Scores' change of Unified Parkinson's Rating Scale (part III/motor part)
时间窗: Before and six-month after DBS.
Compares the scores' change of Unified Parkinson's Rating Scale (part III/motor part) between the two groups.
次要结局
- Scores' change of Montreal Cognitive Assessment(Before and six-month after DBS.)
- Dosage of Anesthetic Drugs(Within surgery.)
- Rates of Adverse Events(Intra-operative.)
- Wake-up Time(Within surgery.)
- Hoehn&Yahr(Before surgery.)
- Scores' change of 39-item Parkinson's Disease Questionnaire(Before and six-month after DBS.)
- Change of Levodopa Equivalent Dose(Before and six-month after DBS.)
- Patients' Satisfaction(Visual Analogue Scale)(24 hours after surgery.)
- Scores' change of Mini-mental State Examination(Before and six-month after DBS.)
- Surgical Time(Within surgery.)
- Scores' change of Hamilton Anxiety Scale(Before and six-month after DBS.)
- Scores' change of Hamilton Depression Scale(Before and six-month after DBS.)
研究者
ZhiHeng Liu
Head of Anesthesiology
Shenzhen Second People's Hospital