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Sedation Versus General Anesthesia for Endovascular Therapy in Acute Stroke - Impact on Neurological Outcome

Sedation Versus General Anesthesia for Endovascular Therapy in Acute Stroke - Impact on Neurological Outcome

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01872884
Acronym
ANSTROKE
Enrollment
90
Registered
2013-06-07
Start date
2013-11-14
Completion date
2016-09-30
Last updated
2017-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke

Keywords

Stroke, Ischemic stroke, Acute stroke, Embolectomy, Endovascular therapy, Intra-arterial therapy, Sedation, Anesthesia

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 addition we study if there is any difference between the methods regarding complication frequency.

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 procedure, the duration of which varies from 2-6 hours, the patient has to remain immobilized. Two techniques are currently used routinely to achieve this. One technique is general anaesthesia, that will ensure that the patient is completely immobile throughout the procedure, which is an advantage from a neuroimaging perspective. A disadvantage is that preparation for, and the induction of anesthesia prolongs the time to embolectomy. Another disadvantage may be that the patient´s blood pressure drops during anesthesia, which could impair the brain blood supply and subsequently neurological outcome. The ability to evaluate the patient's neurological symptoms also disappears. The second technique consists of sedation during surgery. The advantages of this technique are that the time to the beginning of embolectomy is getting shorter and the blood pressure becomes more stable. One drawback is that it cannot guarantee that the patient remains immobile throughout the procedure, which increases the risk of motion artifacts and may lead to the duration of embolectomy becomes prolonged. There is also a risk of hypoventilation and the patient aspirates during surgery. Retrospective studies suggest that patients receiving general anesthesia have worse neurologic outcome three months after stroke. This could be explained by more or less pronounced anesthesia-induced episodes of hypotension, compared with lightly sedated patients with more stable blood pressure. In these retrospective analyzes, however, the patients who received general anesthesia were, neurologically speaking, more ill than patients who only received sedation. This may probably, at least in part, explain why anesthetized patients have a worse neurologic outcome. In these retrospective studies, many centers were involved, with various endovascular and anesthesia procedures.

Interventions

DRUGSevorane Remifentanil

Sevorane Remifentanil

DRUGRemifentanil

Remifentanil

Sponsors

Sahlgrenska University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients with acute stroke considered for thrombectomy and meeting the following inclusion criteria included: 1. the patient is ≥ 18 years 2. the patient has a CT angio verified embolization \* and / or a NIHSS scores \*\* ≥ 10 (R) or 14 (L) depending on the side engagement 3. 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 criteria

1. the patient must receive general anesthesia, for medical reasons, according to the responsible anesthesiologist 2. the patient cannot receive general anesthesia, for medical reasons, according to the responsible anesthesiologist 3. the patient has an embolization of posterior brain vessels 4. CT-confirmed intracerebral hemorrhage 5. spontaneous recanalization or spontaneous neurological improvement 6. any other reason that does not allow embolectomy (co-morbidities) 7. premorbid MRS ≥ 4

Design outcomes

Primary

MeasureTime frameDescription
Neurological outcome in the two different arms90 daysNeurological outcome is measured as modified Rankin Scale (mRS), 90d post stroke.

Secondary

MeasureTime frameDescription
The degree of recanalization and reperfusion1 day (After completed embolectomy)Measures as modified TICI(Thrombolysis In Cerebral Infarction)score
Periprocedural complicationsPerioperatively
Infarction magnitudeDay 1 to Day 90CT (computer tomography scan) Day 1 incl CTperfusion MR (magnetic resonance imaging) on day 3 (2-4) and 3 months Brain damage markers (GFAP, Tau, S-100B) before, 2, 24, 48, 72 hours and 3 months after the procedure.
NIHSS(National Institutes of Health Stroke Scale)Day 3,7,90Change in NIHSS score on day 3, day 7 and 3 months compared to admission to hospital
Time consumptionPeriproceduralTime consumed from: stroke onset to CT angiography, CT angiography to start of anesthesia / sedation, stroke onset to start of embolectomy and duration of embolectomy.
Hospital length of stayApproximately 7-14 daysHospital length of stay
Quantitative EEG changesDay 1,2,90Quantitative EEG (electro encephalography) days 1, 2, and three months after onset

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026