Effect of Stellate Ganglion Block on Postoperative Sleep Status in Patients With Prolonged Disorders of Consciousness: a Single--Centre Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Total sleep time
研究概览
简要总结
The goal of this clinical trial is to learn about the effect of preoperative administration of stellate ganglion block on postoperative sleep status in patients with prolonged disorders of consciousness. The main aims to answer are: • To explore the effect of preoperative administration of stellate ganglion block on postoperative polysomnography and total sleep time in patients with prolonged disorders of consciousness. • To explore the effect of preoperative administration of stellate ganglion block on postoperative cerebral oxygen saturation, cerebral hemodynamic parameters and recovery of consciousness. Participants will be pDoC patients with intact skulls after acquired brain injury who will undergo spinal cord electronic stimulator implantation under general anesthesia at Beijing Tiantan Hospital. Stellate ganglion block will be administrated before the surgery. Polysomnography, total sleep time, cerebral oxygen saturation, cerebral hemodynamic parameters, CRS-R scores, GCS scores, WHIM scores and NCS scores will be investigated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-65 years;
- •Prolonged disorders of consciousness after acquired brain injury;
- •Scheduled to undergo spinal cord electronic stimulator implantation under general anesthesia;
- •The skull is intact;
- •Informed consent is obtained;
排除标准
- •Continuous sedation therapy is performed within 72 hours prior to the study;
- •The integrity of brain structure is disrupted due to causes such as open head injury and cerebral parenchymal resection;
- •Decreased intracranial compliance caused by hydrocephalus and other reasons;
- •Airway stenosis or severe dysfunction of ventilation or gas exchange due to various causes;
- •Known or suspected severe cardiac, pulmonary, and renal dysfunction;
- •History of sedative drug allergy;
- •Complicated by other mental or neurological disorders;
- •Local anesthetic allergy;
- •Other reasons for ineligibility in this study;
- •Informed consent is not obtained;
研究组 & 干预措施
stellate ganglion block
preoperative administration of stellate ganglion block
干预措施: stellate ganglion block with 0.5% ropivacaine (Drug)
结局指标
主要结局
Total sleep time
时间窗: on the first postoperative night
total sleep time on PSG
次要结局
- Length of ICU stay(30 days postoperatively)
- cerebral oxygen saturation(30 minutes after stellate ganglion block)
- cerebral hemodynamic parameters(30 minutes after stellate ganglion block.)
- the recovery of consciousness(1 and 30 days postoperatively)
- Costs of ICU stay(30 days postoperatively)
研究者
Ruquan Han
Director
Beijing Tiantan Hospital