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

Primary Purpose

Ischemic Stroke

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Sevorane Remifentanil
Remifentanil
Sponsored by
Sahlgrenska University Hospital, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ischemic Stroke focused on measuring Stroke, Ischemic stroke, Acute stroke, Embolectomy, Endovascular therapy, Intra-arterial therapy, Sedation, Anesthesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sahlgrenska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

General anaesthesia

Sedation

Arm Description

General anaesthesia with mechanical ventilation. Sevorane Remifentanil. Bloodpressure control, systolic pressure 140-180 mmHg.

Sedation with spontaneous breathing. Remifentanil. Bloodpressure control, systolic pressure 140-180 mmHg

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

NIHSS(National Institutes of Health Stroke Scale)
Change in NIHSS score on day 3, day 7 and 3 months compared to admission to hospital
The degree of recanalization and reperfusion
Measures as modified TICI(Thrombolysis In Cerebral Infarction)score
Periprocedural complications
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.
Quantitative EEG changes
Quantitative EEG (electro encephalography) days 1, 2, and three months after onset
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.
Hospital length of stay
Hospital length of stay

Full Information

First Posted
June 4, 2013
Last Updated
October 10, 2017
Sponsor
Sahlgrenska University Hospital, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT01872884
Brief Title
Sedation Versus General Anesthesia for Endovascular Therapy in Acute Stroke - Impact on Neurological Outcome
Acronym
ANSTROKE
Official Title
Sedation Versus General Anesthesia for Endovascular Therapy in Acute Stroke - Impact on Neurological Outcome
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
November 14, 2013 (Actual)
Primary Completion Date
September 30, 2016 (Actual)
Study Completion Date
September 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahlgrenska University Hospital, Sweden

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
Stroke, Ischemic stroke, Acute stroke, Embolectomy, Endovascular therapy, Intra-arterial therapy, Sedation, Anesthesia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
General anaesthesia
Arm Type
Experimental
Arm Description
General anaesthesia with mechanical ventilation. Sevorane Remifentanil. Bloodpressure control, systolic pressure 140-180 mmHg.
Arm Title
Sedation
Arm Type
Placebo Comparator
Arm Description
Sedation with spontaneous breathing. Remifentanil. Bloodpressure control, systolic pressure 140-180 mmHg
Intervention Type
Drug
Intervention Name(s)
Sevorane Remifentanil
Other Intervention Name(s)
tracheal intubation
Intervention Description
Sevorane Remifentanil
Intervention Type
Drug
Intervention Name(s)
Remifentanil
Other Intervention Name(s)
Conscious sedation
Intervention Description
Remifentanil
Primary Outcome Measure Information:
Title
Neurological outcome in the two different arms
Description
Neurological outcome is measured as modified Rankin Scale (mRS), 90d post stroke.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
NIHSS(National Institutes of Health Stroke Scale)
Description
Change in NIHSS score on day 3, day 7 and 3 months compared to admission to hospital
Time Frame
Day 3,7,90
Title
The degree of recanalization and reperfusion
Description
Measures as modified TICI(Thrombolysis In Cerebral Infarction)score
Time Frame
1 day (After completed embolectomy)
Title
Periprocedural complications
Time Frame
Perioperatively
Title
Infarction magnitude
Description
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.
Time Frame
Day 1 to Day 90
Title
Quantitative EEG changes
Description
Quantitative EEG (electro encephalography) days 1, 2, and three months after onset
Time Frame
Day 1,2,90
Title
Time consumption
Description
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.
Time Frame
Periprocedural
Title
Hospital length of stay
Description
Hospital length of stay
Time Frame
Approximately 7-14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: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 Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandros Rentzos, MD
Organizational Affiliation
Diagnostic and interventional Neuroradiology, Radiology department, Sahlgrenska Academy, University of Gothenburg
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pia Löwhagen Henden, MD
Organizational Affiliation
Anesthesiology, Sahlgrenska Academy, University of Gothenburg
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sven-Erik Ricksten, MD PhD Prof
Organizational Affiliation
Sahlgrenska Academy, University of Gothenburg
Official's Role
Study Director
Facility Information:
Facility Name
Sahlgrenska University Hospital
City
Gothenburg
ZIP/Postal Code
S-413 45 Göteborg
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
20431082
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.
Results Reference
background
PubMed Identifier
20431708
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.
Results Reference
background
PubMed Identifier
20395617
Citation
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.
Results Reference
background
PubMed Identifier
22222475
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.
Results Reference
background
PubMed Identifier
35857365
Citation
Tosello R, Riera R, Tosello G, Clezar CN, Amorim JE, Vasconcelos V, Joao BB, Flumignan RL. Type of anaesthesia for acute ischaemic stroke endovascular treatment. Cochrane Database Syst Rev. 2022 Jul 20;7(7):CD013690. doi: 10.1002/14651858.CD013690.pub2.
Results Reference
derived
PubMed Identifier
28522637
Citation
Lowhagen Henden P, Rentzos A, Karlsson JE, Rosengren L, Leiram B, Sundeman H, Dunker D, Schnabel K, Wikholm G, Hellstrom M, Ricksten SE. General Anesthesia Versus Conscious Sedation for Endovascular Treatment of Acute Ischemic Stroke: The AnStroke Trial (Anesthesia During Stroke). Stroke. 2017 Jun;48(6):1601-1607. doi: 10.1161/STROKEAHA.117.016554.
Results Reference
derived

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

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