Effect of Sevoflurane on vasospastic cerebral vasculature following aneurysmal sah, in patients receiving intra- arterial nimodipine, assessed by digital subtraction angiography :a prospective randomized controlled trial(SIAN-VCV trial)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- Effect on diameter of major cerebral vessels ICA,MCA,ACA
Study Overview
Brief Summary
subarachnoid hemorrhage following rupture of cerebral aneurysm is a life-threatening condition. Who survive many of them suffer from severe neurological and neurocognitive deficits. One of the most dangerous consequences of aneurysmal subarachnoid hemorrhage is cerebral vasospasm described as reversible constriction of cerebral blood vessels, mostly affecting major vessels of circle of Willis . The effectiveness of oral and intra-arterial nimodipine in preventing and treating cerebral vasospasm and decreasing cerebral infraction is well established. Sevoflurane is a cerebral vasodilator. Digital subtraction angiography is a method by which direct vessel can be measured using electronic caliper. Previous study showed that effects of propofol and sevoflurane on cerebral vasculature in patients with aneurysmal subarachnoid hemorrhage using digital subtraction angiography and observed that sevoflurane has vasodilating properties compared to propofol in patients with aneurysmal subarachnoid hemorrhage
Hypothesis is that sevoflurane has synergistic effect of vasodilation with that of intra-arterial nimodipine in patients with cerebral vasospasm following aneurysmal subarachnoid hemorrhage. The mean change in vascular diameter from baseline during nimodipine therapy will be greater under sevoflurane anesthesia than under propofol based anesthesia in patients presenting for intra-arterial nimodipine therapy for vasospasm following aneurysmal subarachnoid hemorrhage.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Adults patients (age 18 yrs) with cerebral vasospasm following aneurysmal subarachnoid hemorrhage posted for intra-arterial nimodipine who are either unconscious,semiconscious,irritable or intubated and need for general anaesthesia for the procedure.
Exclusion Criteria
- •Patient or legal heir’s refusal for consent
- •Patient with H/O allergy to test drugs
- •Patient who received intraarterial Nimodipine previously.
- •Patients having deranged renal parameters
- •Patients with vasculitis.
- •Patient having hydrocephalus.
- •Patients having abnormal coagulation parameters.
Outcomes
Primary Outcomes
Effect on diameter of major cerebral vessels ICA,MCA,ACA
Time Frame: Baseline before giving general anesthesia and after nimodipine administration
Secondary Outcomes
- 1. To assess changes in Cerebral Arterio-Venous Transit Time which is a surrogate marker of the cerebral blood flow by DSA.(2. Cerebral blood flow velocity (SFV/DFV/MFV), Pulsatility Index (PI) and Lindegaard ratio measured by TCD, before the procedure, 1 hour and 24 hours after procedure. These parameters will be measured once daily again for 1-5 days after IA Nimodipine.)
Investigators
Sk Ahadul Islam
Post Graduate Institute of medical education and research