An interventional study of Stellate ganglion block in Aneurysmal Subarachnoid Hemorrhage, Stellate Ganglion Block and Cerebral Vasospasm, sponsored by Beijing Tiantan Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-03-15.
Sponsored by Beijing Tiantan Hospital · Not applicable, Interventional, and Prevention
At present, cerebral vasospasm (cVS) is the main cause of delayed cerebral infarction (DCI), which leads to high disability and mortality rate after aneurysmal subarachnoid hemorrhage. As a consequence, the key of reducing DCI is to prevent cVS. But unfortunately, despite years of efforts, the prevention and treatment of cVS is still a major clinical dilemma and various ways of treatment are still being explored. Recent studies have shown that stellate ganglion block (SGB) can dilate cerebral vessels and alleviate the impact of existing cVS. However, there is no study to evaluate the effect of early application of SGB on the improvement and prevention of cVS after aSAH.
Cerebral vasospasm refers to the extensive segmental or diffuse contraction of cerebral vasculature after aSAH, and cerebral blood flow is significantly reduced, which can lead to delayed cerebral ischemia (DCI) or delayed ischemic neurological dysfunction (DIND). Past studies have shown that if cerebral vasospasm occurs in patients with aSAH, the proportion of ischemic brain injury can be as high as 20%-30%.Obviously, prevention and treatment of CVS are the key to reducing the disability and mortality of aSAH.
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Exclusion Criteria:
In addition to routine anesthesia management and surgical operations, a stellate ganglion block was performed before induction of anesthesia, and then receive standard care after operation. Related statistical indicators were collected prospectively.
Procedure: Stellate ganglion block
In this study, a blank control was used. Routine anesthesia management and surgical operation were used without any special interventions(only an camouflaging action), and then receive standard care after operation. Only relevant statistical indicators were collected prospectively.
After the patient entered the operating room, early SGB will be performed by a designated experienced anesthesiologist using the B-ultrasound visualization technique. The intervention site is the ipsilateral side of the planned craniotomy site. After routine disinfection, 0.5% ropivacaine 8-10 mL will be injected into the surface of the longus colli muscle on the medial side of the prevertebral fascia at the level of the C6 anterior tubercle, and then the puncture point will be covered with sterile dressings. The success criteria of e-SGB are Horner's syndrome, which is characterized by a miosis, ptosis, enophthalmos, conjunctival hyperemia and facial reddishness without sweating. For the "camouflaging" arm, the anesthesiologist only covered the corresponding part of the patient with sterile dressings to confuse the follow-up, without any puncture. All patients will be admitted to the ICU after the operation and then receive the standard of care.
The incidence of symptomatic vasospasm during hospitalization
Symptomatic vasospasm is defined as new focal or global neurological dysfunction or a decrease in the Glasgow coma score by more than 2 points, and with angiographic vasospasm on TCD or CTA.
Time frame: an average of 2 weeks
The incidence of TCD vasospasm during hospitalization
The mean blood flow velocity (MFV) of the middle cerebral artery ≥ 120 cm/s or Lindegaard index (ratio of MFV of the middle cerebral artery to the internal carotid artery) ≥ 3.
Time frame: on the days 3-5 after operation
The incidence of CTA vasospasm on the days 3-5 after operation
Compared with the preoperative baseline, the corresponding vessel diameter narrowed by more than 30% or new segmental stenosis occurred, not related to atherosclerosis or mechanical artery stenosis caused by arterial clamps or coils.
Time frame: on the days 3-5 after operation
The incidence of hypoperfusion in CTP diagnosis on the days 3-5 after operation
The incidence of hypoperfusion in CTP diagnosis
Time frame: on the days 3-5 after operation
The incidence of new cerebral infarction observed on the days 90 after operation and discharge .
New cerebral infarction is defined only as the appearance of new low-density infarct shadow on CT image compared with preoperation.
Time frame: on the days 90 after operation and discharge
The changes of he mean blood flow velocity (mBFV) after operation
the changes in the mean blood flow velocity (mBFV) of all large intracranial anterior circulation vessels
Time frame: on the days 3-5 after operation
Total length of stay in the intensive care unit and hospital.
Days
Time frame: on the 90 days
The modified Rankin scale at discharge, 30days, and 90 days
The modified Rankin scale ≤2 is defined as good prognosis
Time frame: on the 30 and 90 days
All-cause mortality rate up to 90 days.
The rate
Time frame: on the 90 days
Postoperative delirium incidence during hospitalization
The rate
Time frame: on the days 1-3 after operation
Postoperative cognitive dysfunction
The rate
Time frame: At discharge，an average of 2 weeks
The proportion of remedial treatment after CVS
The rate
Time frame: At discharge，an average of 2 weeks
Adverse events during hospitalization
Myocardial infarction, cardiac arrest, pulmonary embolism, infection, SGB related complications, etc
Time frame: At discharge，an average of 2 weeks
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Beijing Tiantan Hospital