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

Ischemic Stroke Clinical Trial

— ANSTROKE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01872884
• Other study ID #: ANSTROKE
• Secondary ID: ALFGBG-75870
• Status: Completed
• Phase: N/A
• First received: June 4, 2013
• Last updated: October 10, 2017
• Start date: November 14, 2013
• Est. completion date: September 30, 2016

Study information

• Verified date: October 2017
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 30, 2016
• Est. primary completion date: September 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke

Intervention

Drug:
• Sevorane Remifentanil
Sevorane Remifentanil
• Remifentanil
Remifentanil

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

References & Publications (4)

Abou-Chebl A, Lin R, Hussain MS, Jovin TG, Levy EI, Liebeskind DS, Yoo AJ, Hsu DP, Rymer MM, Tayal AH, Zaidat OO, Natarajan SK, Nogueira RG, Nanda A, Tian M, Hao Q, Kalia JS, Nguyen TN, Chen M, Gupta R. Conscious sedation versus general anesthesia during endovascular therapy for acute anterior circulation stroke: preliminary results from a retrospective, multicenter study. Stroke. 2010 Jun;41(6):1175-9. doi: 10.1161/STROKEAHA.109.574129. Epub 2010 Apr 15. — View Citation

Davis MJ, Menon BK, Baghirzada LB, Campos-Herrera CR, Goyal M, Hill MD, Archer DP; Calgary Stroke Program. Anesthetic management and outcome in patients during endovascular therapy for acute stroke. Anesthesiology. 2012 Feb;116(2):396-405. doi: 10.1097/ALN.0b013e318242a5d2. — View Citation

Jumaa MA, Zhang F, Ruiz-Ares G, Gelzinis T, Malik AM, Aleu A, Oakley JI, Jankowitz B, Lin R, Reddy V, Zaidi SF, Hammer MD, Wechsler LR, Horowitz M, Jovin TG. Comparison of safety and clinical and radiographic outcomes in endovascular acute stroke therapy for proximal middle cerebral artery occlusion with intubation and general anesthesia versus the nonintubated state. Stroke. 2010 Jun;41(6):1180-4. doi: 10.1161/STROKEAHA.109.574194. Epub 2010 Apr 29. — View Citation

Nichols C, Carrozzella J, Yeatts S, Tomsick T, Broderick J, Khatri P. Is periprocedural sedation during acute stroke therapy associated with poorer functional outcomes? J Neurointerv Surg. 2010 Mar;2(1):67-70. doi: 10.1136/jnis.2009.001768. Epub 2009 Dec 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurological outcome in the two different arms	Neurological outcome is measured as modified Rankin Scale (mRS), 90d post stroke.	90 days
Secondary	NIHSS(National Institutes of Health Stroke Scale)	Change in NIHSS score on day 3, day 7 and 3 months compared to admission to hospital	Day 3,7,90
Secondary	The degree of recanalization and reperfusion	Measures as modified TICI(Thrombolysis In Cerebral Infarction)score	1 day (After completed embolectomy)
Secondary	Periprocedural complications		Perioperatively
Secondary	Infarction magnitude	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.	Day 1 to Day 90
Secondary	Quantitative EEG changes	Quantitative EEG (electro encephalography) days 1, 2, and three months after onset	Day 1,2,90
Secondary	Time consumption	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
Secondary	Hospital length of stay	Hospital length of stay	Approximately 7-14 days