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

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ClinicalTrials.gov Identifier: NCT01872884
Recruitment Status : Completed
First Posted : June 7, 2013
Last Update Posted : October 11, 2017
Sponsor:
Information provided by (Responsible Party):
Alexandros Rentzos, Sahlgrenska University Hospital, Sweden

Tracking Information
First Submitted Date  ICMJE June 4, 2013
First Posted Date  ICMJE June 7, 2013
Last Update Posted Date October 11, 2017
Actual Study Start Date  ICMJE November 14, 2013
Actual Primary Completion Date September 30, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2013)
Neurological outcome in the two different arms [ Time Frame: 90 days ]
Neurological outcome is measured as modified Rankin Scale (mRS), 90d post stroke.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01872884 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2017)
  • NIHSS(National Institutes of Health Stroke Scale) [ Time Frame: 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 [ Time Frame: 1 day (After completed embolectomy) ]
    Measures as modified TICI(Thrombolysis In Cerebral Infarction)score
  • Periprocedural complications [ Time Frame: Perioperatively ]
  • Infarction magnitude [ Time Frame: 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.
  • Quantitative EEG changes [ Time Frame: Day 1,2,90 ]
    Quantitative EEG (electro encephalography) days 1, 2, and three months after onset
  • Time consumption [ Time Frame: 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.
  • Hospital length of stay [ Time Frame: Approximately 7-14 days ]
    Hospital length of stay
Original Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2013)
  • NIHSS(National Institutes of Health Stroke Scale) [ Time Frame: 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 [ Time Frame: 1 day (After completed embolectomy) ]
    Measures as modified TIMI(Thrombolysis In Myocardial Infarction)score
  • Periprocedural complications [ Time Frame: Perioperatively ]
  • Infarction magnitude [ Time Frame: Day 1 to Day 90 ]
    CT (computer tomography)scan) Day 1 incl perfusion / CT angio 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 [ Time Frame: Day 1,2,90 ]
    Quantitative EEG (electro encephalography) days 1, 2, and three months after onset
  • Time consumption [ Time Frame: 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.
  • Hospital length of stay [ Time Frame: Approximatly 7-14 days ]
    Hospital length of stay
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sedation Versus General Anesthesia for Endovascular Therapy in Acute Stroke - Impact on Neurological Outcome
Official Title  ICMJE Sedation Versus General Anesthesia for Endovascular Therapy in Acute Stroke - Impact on Neurological Outcome
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Ischemic Stroke
Intervention  ICMJE
  • Drug: Sevorane Remifentanil
    Sevorane Remifentanil
    Other Name: tracheal intubation
  • Drug: Remifentanil
    Remifentanil
    Other Name: Conscious sedation
Study Arms  ICMJE
  • Experimental: General anaesthesia
    General anaesthesia with mechanical ventilation. Sevorane Remifentanil. Bloodpressure control, systolic pressure 140-180 mmHg.
    Intervention: Drug: Sevorane Remifentanil
  • Placebo Comparator: Sedation
    Sedation with spontaneous breathing. Remifentanil. Bloodpressure control, systolic pressure 140-180 mmHg
    Intervention: Drug: Remifentanil
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 6, 2013)
90
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 30, 2016
Actual Primary Completion Date September 30, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01872884
Other Study ID Numbers  ICMJE ANSTROKE
ALFGBG-75870 ( Other Grant/Funding Number: Swedish State Support for Clinical Research (ALFGBG-75870) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Alexandros Rentzos, Sahlgrenska University Hospital, Sweden
Study Sponsor  ICMJE Sahlgrenska University Hospital, Sweden
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alexandros Rentzos, MD Diagnostic and interventional Neuroradiology, Radiology department, Sahlgrenska Academy, University of Gothenburg
Principal Investigator: Pia Löwhagen Henden, MD Anesthesiology, Sahlgrenska Academy, University of Gothenburg
Study Director: Sven-Erik Ricksten, MD PhD Prof Sahlgrenska Academy, University of Gothenburg
PRS Account Sahlgrenska University Hospital, Sweden
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP