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Trial record 1 of 1 for:    NCT01872884
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Sedation Versus General Anesthesia for Endovascular Therapy in Acute Stroke - Impact on Neurological Outcome (ANSTROKE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Alexandros Rentzos, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier:
NCT01872884
First received: June 4, 2013
Last updated: September 4, 2016
Last verified: September 2016
  Purpose
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.

Condition Intervention
Ischemic Stroke Drug: Sevorane Remifentanil Drug: Remifentanil

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Sedation Versus General Anesthesia for Endovascular Therapy in Acute Stroke - Impact on Neurological Outcome

Resource links provided by NLM:


Further study details as provided by Alexandros Rentzos, Sahlgrenska University Hospital, Sweden:

Primary Outcome Measures:
  • Neurological outcome in the two different arms [ Time Frame: 90 days ]
    Neurological outcome is measured as modified Rankin Scale (mRS), 90d post stroke.


Secondary Outcome Measures:
  • 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: Approximatly 7-14 days ]
    Hospital length of stay


Enrollment: 90
Study Start Date: June 2013
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: General anaesthesia
General anaesthesia with mechanical ventilation. Sevorane Remifentanil. Bloodpressure control, systolic pressure 140-180 mmHg.
Drug: Sevorane Remifentanil
Sevorane Remifentanil
Other Name: tracheal intubation
Placebo Comparator: Sedation
Sedation with spontaneous breathing. Remifentanil. Bloodpressure control, systolic pressure 140-180 mmHg
Drug: Remifentanil
Remifentanil
Other Name: Conscious sedation

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01872884

Locations
Sweden
Sahlgrenska University Hospital
Gothenburg, Sweden, S-413 45 Göteborg
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Investigators
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
  More Information

Publications:
Responsible Party: Alexandros Rentzos, MD, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT01872884     History of Changes
Other Study ID Numbers: ANSTROKE
ALFGBG-75870 ( Other Grant/Funding Number: Swedish State Support for Clinical Research (ALFGBG-75870) )
Study First Received: June 4, 2013
Last Updated: September 4, 2016
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Alexandros Rentzos, Sahlgrenska University Hospital, Sweden:
Stroke
Ischemic stroke
Acute stroke
Embolectomy
Endovascular therapy
Intra-arterial therapy
Sedation
Anesthesia

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Anesthetics
Sevoflurane
Remifentanil
Central Nervous System Depressants
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Anesthetics, Intravenous

ClinicalTrials.gov processed this record on June 23, 2017