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Stellate Ganglion Block and Prognosis of Neurological Function After Subarachnoid Hemorrhage

ConditionsAneurysmal Subarachnoid HemorrhageStellate Ganglion BlockNeurological Prognosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBeijing Tiantan Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intervention group

    Procedure/Surgery

    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

Treatment groups

560 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: Blank control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

The modified Rankin Scale (mRS) scores at 90 days

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.

Time frame
90 days postoperatively

Secondary outcomes

1

The incidence of delayed cerebral ischemia (DCI) during hospitalization

Time frame
At discharge, an average of 2 weeks
2

All cause mortality during 90 days after onset

Time frame
90 days postoperatively
3

Length of stay in the intensive care unit and hosipital

Time frame
At discharge, an average of two weeks
4

Adverse events during hospitalization

Myocardial infarction, cardiac arrest, pulmonary embolism, infection, SGB related complications, etc

Time frame
At discharge, an average of 2 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Tiantan Hospital

Lead sponsor

Source ClinicalTrials.gov

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