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

Not Applicable

Completed

• Conditions: Ischemic Stroke
• Interventions: Drug: Sevorane Remifentanil; Drug: Remifentanil

• Registration Number: NCT01872884
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

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.

Study Timeline

• Study First Submitted: 2013-06-04
• Study First Submitted QC: 2013-06-06
• Study First Posted: 2013-06-07
• Study Start: 2013-11-14
• Primary Completion: 2016-09-30
• Study Completion: 2016-09-30
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-10
• Last Update Posted: 2017-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
General anaesthesia	Sevorane Remifentanil	General anaesthesia with mechanical ventilation. Sevorane Remifentanil. Bloodpressure control, systolic pressure 140-180 mmHg.
Sedation	Remifentanil	Sedation with spontaneous breathing. Remifentanil. Bloodpressure control, systolic pressure 140-180 mmHg

Primary Outcome Measures

Name	Time	Method
Neurological outcome in the two different arms	90 days	Neurological outcome is measured as modified Rankin Scale (mRS), 90d post stroke.

Secondary Outcome Measures

Name	Time	Method
NIHSS(National Institutes of Health Stroke Scale)	Day 3,7,90	Change in NIHSS score on day 3, day 7 and 3 months compared to admission to hospital
The degree of recanalization and reperfusion	1 day (After completed embolectomy)	Measures as modified TICI(Thrombolysis In Cerebral Infarction)score
Infarction magnitude	Day 1 to Day 90	CT (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.
Hospital length of stay	Approximately 7-14 days	Hospital length of stay
Quantitative EEG changes	Day 1,2,90	Quantitative EEG (electro encephalography) days 1, 2, and three months after onset
Time consumption	Periprocedural	Time consumed from: stroke onset to CT angiography, CT angiography to start of anesthesia / sedation, stroke onset to start of embolectomy and duration of embolectomy.
Periprocedural complications	Perioperatively

Trial Locations

Locations (1)

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden