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

October 10, 2017 updated by: Alexandros Rentzos, Sahlgrenska University Hospital, Sweden
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Gothenburg, Sweden, S-413 45 Göteborg
        • Sahlgrenska university hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: General anaesthesia
General anaesthesia with mechanical ventilation. Sevorane Remifentanil. Bloodpressure control, systolic pressure 140-180 mmHg.
Drug: Sevorane Remifentanil
Sevorane Remifentanil
Other Names:
  • tracheal intubation
Placebo Comparator: Sedation
Sedation with spontaneous breathing. Remifentanil. Bloodpressure control, systolic pressure 140-180 mmHg
Drug: Remifentanil
Remifentanil
Other Names:
  • Conscious sedation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurological outcome in the two different arms
Time Frame: 90 days
Neurological outcome is measured as modified Rankin Scale (mRS), 90d post stroke.
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 3,7,90
The degree of recanalization and reperfusion
Time Frame: 1 day (After completed embolectomy)
Measures as modified TICI(Thrombolysis In Cerebral Infarction)score
1 day (After completed embolectomy)
Periprocedural complications
Time Frame: Perioperatively
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.
Day 1 to Day 90
Quantitative EEG changes
Time Frame: Day 1,2,90
Quantitative EEG (electro encephalography) days 1, 2, and three months after onset
Day 1,2,90
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.
Periprocedural
Hospital length of stay
Time Frame: Approximately 7-14 days
Hospital length of stay
Approximately 7-14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2013

Primary Completion (Actual)

September 30, 2016

Study Completion (Actual)

September 30, 2016

Study Registration Dates

First Submitted

June 4, 2013

First Submitted That Met QC Criteria

June 6, 2013

First Posted (Estimate)

June 7, 2013

Study Record Updates

Last Update Posted (Actual)

October 11, 2017

Last Update Submitted That Met QC Criteria

October 10, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANSTROKE
  • ALFGBG-75870 (Other Grant/Funding Number: Swedish State Support for Clinical Research (ALFGBG-75870))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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