Status:
COMPLETED
Sedation Versus General Anesthesia for Endovascular Therapy in Acute Stroke - Impact on Neurological Outcome
Lead Sponsor:
Sahlgrenska University Hospital
Conditions:
Ischemic Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate whether general anesthesia or sedation technique is preferable during embolectomy for stroke, measured in terms of three months neurological impairment. In add...
Detailed Description
Stroke is a common cause of neurological disability. Early diagnosis of ischemic stroke now enables treatment with thrombolysis and / or endovascular therapy (embolectomy). In order to implement this ...
Eligibility Criteria
Inclusion
- Patients with acute stroke considered for thrombectomy and meeting the following inclusion criteria included:
- the patient is ≥ 18 years
- the patient has a CT angio verified embolization \* and / or a NIHSS scores \*\* ≥ 10 (R) or 14 (L) depending on the side engagement
- embolectomy (= groin puncture) started \<8 hours after symptom onset
- Embolus in one of the following arteries: internal carotid artery, anterior cerebral (A1 segment), cerebri media (M1 segment) and proximal cerebri media branches (M2 segment).
- NIHSS (National Institutes of Health Stroke Scale). Patients with embolus in left hemisphere circulation require ≥ 14 points, while patients with embolus in the right hemisphere circulation require ≥ 10 points. This is because occlusion on the right side does not usually cause aphasia, a symptom that usually leads to higher total score of NIHSS.
Exclusion
- the patient must receive general anesthesia, for medical reasons, according to the responsible anesthesiologist
- the patient cannot receive general anesthesia, for medical reasons, according to the responsible anesthesiologist
- the patient has an embolization of posterior brain vessels
- CT-confirmed intracerebral hemorrhage
- spontaneous recanalization or spontaneous neurological improvement
- any other reason that does not allow embolectomy (co-morbidities)
- premorbid MRS ≥ 4
Key Trial Info
Start Date :
November 14 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2016
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT01872884
Start Date
November 14 2013
End Date
September 30 2016
Last Update
October 11 2017
Active Locations (1)
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1
Sahlgrenska University Hospital
Gothenburg, Sweden, S-413 45 Göteborg