Sedation Versus General Anesthesia for Endovascular Therapy in Acute Stroke - Impact on Neurological Outcome
NCT ID: NCT01872884
Last Updated: 2017-10-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2013-11-14
2016-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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General anaesthesia
General anaesthesia with mechanical ventilation. Sevorane Remifentanil. Bloodpressure control, systolic pressure 140-180 mmHg.
Sevorane Remifentanil
Sevorane Remifentanil
Sedation
Sedation with spontaneous breathing. Remifentanil. Bloodpressure control, systolic pressure 140-180 mmHg
Remifentanil
Remifentanil
Interventions
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Sevorane Remifentanil
Sevorane Remifentanil
Remifentanil
Remifentanil
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Sahlgrenska University Hospital
OTHER
Responsible Party
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Alexandros Rentzos
MD
Principal Investigators
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Alexandros Rentzos, MD
Role: PRINCIPAL_INVESTIGATOR
Diagnostic and interventional Neuroradiology, Radiology department, Sahlgrenska Academy, University of Gothenburg
Pia Löwhagen Henden, MD
Role: PRINCIPAL_INVESTIGATOR
Anesthesiology, Sahlgrenska Academy, University of Gothenburg
Sven-Erik Ricksten, MD PhD Prof
Role: STUDY_DIRECTOR
Sahlgrenska Academy, University of Gothenburg
Locations
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Sahlgrenska University Hospital
Gothenburg, , Sweden
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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ALFGBG-75870
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
ANSTROKE
Identifier Type: -
Identifier Source: org_study_id