Evaluation of the Benefit Provided by the Addition of Acupunctural Analgesia With Electrostimulation to Conventional Local Anesthesia Compared to Conventional Local Anesthesia Alone in Surgery of Deep Brain Stimulation for Movement Disorders.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Patient comfort, judged by "Edmonton Symptom Assessment System" scale (ESAS)
研究概览
简要总结
The effectiveness of Deep Brain Stimulation (DBS) in certain movement disorders is widely demonstrated. The success of this procedure requires that the patient is awake and cooperative. The conditions of this intervention can be difficult to tolerate by the patient for several reasons: long procedure (from 3 to 8 hours), body immobilisation (particularly the head in the stereotactic frame), stress related to the localization of the DBS. It is therefore important to improve the comfort as well as the cooperation of the patient, during implantation of the DBS electrodes, in order to optimize the conditions of the intervention. In addition to analgesia, acupuncture should allow sedation without affecting alertness and should contribute to the regulation of any vegetative reactions during the procedure. Therefore, we hypothesize that acupuncture could improve the quality of care of the patient during a DBS procedure. In practice, this is electroacupuncture that will be used in this research to maintain the stimulation of acupuncture points to an optimal level during the time of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients from both sexes aged who are >= 18 years
- •Disabling movement disorders, resistant to medical treatment, in Parkinson's patients who should benefit from a Deep Brain Stimulation in the subthalamic nucleus
- •Scheduled intervention of a Deep Brain Stimulation
- •Understanding of acupunctural analgesia with electrostimulation
- •Signed informed consent
- •Membership to a social security insurance scheme
排除标准
- •Patients who are >= 75 years
- •History of intolerance to acupuncture
- •Contraindications to local anesthesia
- •Respiratory problems (asthma, COPD, ...)
- •Holder of an implanted pacemaker
- •Obesity with BMI > 30
- •History of motion sickness
- •Unstabilized psychiatric disorders
- •Impaired cognitive functions
- •Pregnancy
- •Breastfeeding
- •Major under a legal protection regime
研究组 & 干预措施
Local anesthesia alone
干预措施: Local Anesthesia (lidocaine hydrochloride) (Drug)
Local Anesthesia + Electroacupuncture
干预措施: Electroacupuncture (Procedure)
Local Anesthesia + Electroacupuncture
干预措施: Local Anesthesia (lidocaine hydrochloride) (Drug)
结局指标
主要结局
Patient comfort, judged by "Edmonton Symptom Assessment System" scale (ESAS)
时间窗: The day of the DBS procedure
次要结局
- Patient anxiety, judged by Hamilton anxiety scale (HAMA)(The day before the DBS procedure, the day of the DBS procedure, 2 days after the DBS procedure)
- Adverse effects(The day before the DBS procedure,the day of the DBS procedure, 2 days after the DBS procedure)
- Drug consumption(The day of the DBS procedure, 2 days after the DBS procedure)
- Anesthesia monitoring parameters: heart rate, blood pressure, pulse oximetry(The day of the DBS procedure, 2 days after the DBS procedure)