Stellate Ganglion Block and Prognosis of Neurological Function After Subarachnoid Hemorrhage
Effect of Stellate Ganglion Block on the Prognosis of Neurological Function After Subarachnoid Hemorrhage
The incidence of cerebral vasospasm after aneurysm subarachnoid hemorrhage (aSAH) is as high as 70%; cerebral vasospasm(CVS) is closely related to delayed cerebral ischemia (DCI), which is one of the important reasons for poor outcomes in patients with aSAH.
In recent years, it has been reported that stellate ganglion block(SGB) can effectively alleviate cerebral vasospasm(CVS), reduce cerebral blood flow velocity and increase cerebral perfusion in patients with aneurysm subarachnoid hemorrhage(aSAH)。However, whether the alleviation of CVS after SGB is beneficial to the long-term neurological prognosis has not been confirmed Therefore, a prospective randomized controlled study is needed to further explore the role of SGB block in improving the outcomes of patients with aSAH.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Ruquan Han, M.D., Ph.D
- 电话号码:8610-59976660
- 邮箱:ruquan.han@gmail.com
学习地点
-
-
Beijing Municipality
-
Beijing、Beijing Municipality、中国、100070
- Beijing Tiantan Hospital, Capital Medical University
-
接触:
- Ruquan Han, M.D., Ph.D
- 电话号码:8610-59976660
- 邮箱:ruquan.han@gmail.com
-
首席研究员:
- Ruquan Han, M.D., Ph.D
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Age range: 18-65 years old;
- Within 72 hours after onset of aSAH,and planning surgical treatment(aneurysm embolizing or clipping);
- Preoperative Hunt-Hess grade 2-3
- Sign informed consent.
Exclusion Criteria:
- ASA > grade IV;
- Patients with posterior circulation aneurysm;
- Patients with severe systemic hemorrhagic diseases;
- Patients with trauma and local infection in the nerve block area;
- Local anatomic structure changes (neck structure changes caused by radiotherapy, chemotherapy and surgery);
- Allergy to known local anesthetics;
- Pregnant and lactating women.
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Intervention group
In addition to routine anesthesia management and surgical operations, an ultrasound-guided stellate ganglion block was performed once prior to the initiation of surgery, and then receive standard care after operation.
Related statistical indicators were collected prospectively.
|
Prior to the initiation of surgery, a single ultrasound-guided stellate ganglion block was performed on the ipsilateral side of the lesion.The dose and concentration of local anesthesia: 0.5% ropivacaine 5-10ml.
Criteria for successful block: the patient developed Horner's syndrome, characterized by miosis, ptosis, eyeball caved in, nasal congestion, conjunctival congestion, reddish face and no sweat on the face
其他名称:
|
|
无干预:Blank control group
In this study, a blank control was used.
Routine anesthesia management and surgical operation were used without any special interventions, and then receive standard care after operation.
Only relevant statistical indicators were collected prospectively.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The modified Rankin Scale (mRS) scores at 90 days
大体时间:90 days postoperatively
|
The modified Rankin Scale (mRS) is used to evaluate the primary outcome.
The scale of mRS is 0 to 6.
The best neurological outcome is the mRS with 0, indicating no any symptom left.
mRS of 6 is the worst, indicating death.
mRS will be evaluated by outcomes assessor who is blinded to the grouping.
|
90 days postoperatively
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The incidence of delayed cerebral ischemia (DCI) during hospitalization
大体时间:At discharge, an average of 2 weeks
|
At discharge, an average of 2 weeks
|
|
|
All cause mortality during 90 days after onset
大体时间:90 days postoperatively
|
90 days postoperatively
|
|
|
Length of stay in the intensive care unit and hosipital
大体时间:At discharge, an average of two weeks
|
At discharge, an average of two weeks
|
|
|
Adverse events during hospitalization
大体时间:At discharge, an average of 2 weeks
|
Myocardial infarction, cardiac arrest, pulmonary embolism, infection, SGB related complications, etc
|
At discharge, an average of 2 weeks
|
合作者和调查者
调查人员
- 首席研究员:Ruquan Han, M.D., Ph.D、Beijing Tiantan Hospital
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.