A prospective randomized study to determine the effect of perioperative stellate ganglion block on cerebral vasospasm in aneurysmal subarachnoid haemorrhage patients.
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- PRIMARY OUTCOME - To compare the incidence of TCD defined cerebral vasospasm MCA or ACA velocity more than 120cm per second in patients receiving perioperative Stellate Ganglion Block versus standard treatment group which is the control group here.
Study Overview
Brief Summary
Patients will be enrolled based on the following inclusion and exclusion criteria. Patients with aSAH diagnosed by imaging (CTA or DSA) and scheduled for surgical intervention within the time period of 72h after ictus will be assessed for recruitment.All TCD measurements would be performed by another observer who would be blinded to the intervention received in the patients. TCD will be monitored by VIASONIX Dolphin/4D model by Viasonix Ltd, Israel. TCD monitoring will be performed before surgery (T0) baseline and on the subsequent post operative days, 1st (T1), 2nd (T2), 3rd (T3), 5th (T4) and 7th (T5) after the operation or earlier if discharged from ICU before 7 days. The incidence of complications, including myocardial infarction, postoperative rebleeding, moderate and severe brain oedema, pulmonary embolism, deep venous thrombosis, SGB-related complications, unexpected adverse events and intra operative complications will also be recorded.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant, Investigator and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •18 years to 65 years, Anterior circulation aneurysms, Planned aneurysm clipping, Pre operative Hunt and Hess grade I II and III.
Exclusion Criteria
- •ASA physical status more than III Posterior circulation aneurysm Multiple aneurysms Allergy to known local anaesthetics Pregnant women.
Outcomes
Primary Outcomes
PRIMARY OUTCOME - To compare the incidence of TCD defined cerebral vasospasm MCA or ACA velocity more than 120cm per second in patients receiving perioperative Stellate Ganglion Block versus standard treatment group which is the control group here.
Time Frame: TCD will be used to measure cerebral blood flow velocity in MCA or ACA preoperatively day 0 and after surgery on day 1,2,3,5 and 7th day.
Secondary Outcomes
- Incidence of symptomatic cerebral vasospasm within 14 days after aSAH(Any additional intervention done for cerebral vasospasm)
Investigators
Dr Rajat Chauhan
All India Institute of medical Sciences, New Delhi