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

NCT01872884 | Completed DMC

• 2 other identifiers: ANSTROKEALFGBG-75870
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke

Keywords

Stroke; Ischemic stroke; Acute stroke; Embolectomy; Endovascular therapy; Intra-arterial therapy; Sedation; Anesthesia

Outcome Measures

Primary Outcomes (1)

• Neurological outcome in the two different arms

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

  90 days

Secondary Outcomes (7)

• NIHSS(National Institutes of Health Stroke Scale)

  Day 3,7,90

• The degree of recanalization and reperfusion

  1 day (After completed embolectomy)

• Periprocedural complications

  Perioperatively

• Infarction magnitude

  Day 1 to Day 90

• Quantitative EEG changes

  Day 1,2,90

Study Arms (2)

General anaesthesia

EXPERIMENTAL

General anaesthesia with mechanical ventilation. Sevorane Remifentanil. Bloodpressure control, systolic pressure 140-180 mmHg.

Drug: Sevorane Remifentanil

Sedation

PLACEBO COMPARATOR

Sedation with spontaneous breathing. Remifentanil. Bloodpressure control, systolic pressure 140-180 mmHg

Drug: Remifentanil

Interventions

Sevorane Remifentanil DRUG

Sevorane Remifentanil

Also known as: tracheal intubation

General anaesthesia

Remifentanil DRUG

Remifentanil

Also known as: Conscious sedation

Sedation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, S-413 45 Göteborg, Sweden

Location

Related Publications (6)

• 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.

  PMID: 20431082 BACKGROUND

• 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.

  PMID: 20431708 BACKGROUND

• 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.

  PMID: 20395617 BACKGROUND

• 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.

  PMID: 22222475 BACKGROUND

• 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.

  PMID: 35857365 DERIVED

• 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.

  PMID: 28522637 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Interventions

Intubation, Intratracheal; Remifentanil; Conscious Sedation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Intubation; Investigative Techniques; Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anesthesia and Analgesia

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Sven-Erik Ricksten, MD PhD Prof

  Sahlgrenska Academy, University of Gothenburg

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 4, 2013
• First Posted: June 7, 2013
• Study Start: November 14, 2013
• Primary Completion: September 30, 2016
• Study Completion: September 30, 2016
• Last Updated: October 11, 2017

Record last verified: 2017-10

Locations

SE (1)