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Completed

NCT Number: NCT01872884

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sahlgrenska University Hospital

Gothenburg, S-413 45 Göteborg, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sevorane Remifentanil

Drug

Sevorane Remifentanil

Other names: tracheal intubation

Remifentanil

Drug

Remifentanil

Other names: Conscious sedation

Primary outcomes

  1. Neurological outcome in the two different arms

    Time frame: 90 days

    Neurological outcome is measured as modified Rankin Scale (mRS), 90d post stroke.

Secondary outcomes

  1. 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

  2. The degree of recanalization and reperfusion

    Time frame: 1 day (After completed embolectomy)

    Measures as modified TICI(Thrombolysis In Cerebral Infarction)score

  3. Periprocedural complications

    Time frame: Perioperatively

  4. 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.

  5. Quantitative EEG changes

    Time frame: Day 1,2,90

    Quantitative EEG (electro encephalography) days 1, 2, and three months after onset

  6. 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.

  7. Hospital length of stay

    Time frame: Approximately 7-14 days

    Hospital length of stay

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Registry information

Acronym: ANSTROKE

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jun 7, 2013
Registry last updated
Oct 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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