Effect of intravenous anaesthetics versus inhalational anaesthetics on delayed cerebral ischemia following aneurysmal sah: a randomised clinical trial (IVIA-DAS)
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- To compare the incidence of delayed cerebral ischemia in patients undergoing
Study Overview
Brief Summary
This trial is designed to see the effect of anaesthesia drugs on the incidence of delayed cerebral ischemia in patients of aneurysmal subarachnoid haemorrhage undergoing surgical clipping of the neck of aneurysm. after randomly dividing into two groups, patients of one group will receive propofol( intravenous) as an anaesthetic agent, while the other will receive sevoflurane ( inhalational) as the anaesthetic agent. Postoperatively these patients are followed up to compare the incidence of Delayed cerebral ischemia between the two groups. Secondarily we reach CSF levels of the eNOS enzyme, collected at the time of surgery. we also check neurological outcomes using MRS scoring at discharge and both MRS and GOSE scale at 1 month and w3 months.w
Study Design
- Study Type
- Interventional
- Allocation
- Random Number Table
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Ruptured aneurysm posted for Surgical Clipping WFNS grade 1,2,3 Anterior circulation aneurysm.
Exclusion Criteria
- •Postictal day 4 or more Postoperative neurological deterioration due to surgical or systemic causes Hydrocephalus.
Outcomes
Primary Outcomes
To compare the incidence of delayed cerebral ischemia in patients undergoing
Time Frame: starting after the surgery till the discharge from hospital
to propofol.
Time Frame: starting after the surgery till the discharge from hospital
clipping of aneurysm surgery under general anesthesia with sevoflurane when compared
Time Frame: starting after the surgery till the discharge from hospital
Secondary Outcomes
- Estimation of CSF eNOS levels(intraoperative ( during aneurysm Clipping surgery))
- Neurological outcome at discharge ( MRS score)(at discharge)
- Neurological outcome at 3 months post surgery(GOSE, MRS score)(1 months after surgery, 3 months after surgery)