GA vs. CS for Endovascular Stroke Therapy

NCT03247998 | Unknown

• 1 other identifier: GA Stroke
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

After a stroke caused by a blockage (clot) in a blood vessel in the brain, patients may have the clot removed by threading a catheter from the groin up to the affected area of the brain. An anesthesiologist is involved in the patient's care during this procedure to maximize patient safety and procedural efficiency. The options for anesthesia for this procedure are general anesthesia (where the patient is unconscious) or sedation (where the patient is in a relaxed, calm, sleepy condition). Currently, it is unclear which of these anesthetic options contributes to the best patient outcome. The investigators would like to investigate whether or not one method of anesthesia (general or sedation) is better to use than the other when removing the clot.

Conditions

Stroke; Endovascular Repair; Anesthesia

Keywords

Stroke; endovascular repair; general anesthesia; conscious sedation

Outcome Measures

Primary Outcomes (1)

• Randomization potential

  Total number of participants that have been recruited and the drop out rates. Recruitment goal is 20 patients within 20 weeks.

  20 weeks

Secondary Outcomes (2)

• Number of participants that complete the recruitment procedure prior to start of endovascular treatment.

  20 weeks

• Length of time to complete/completeness of study-related assessments

  1 year

Study Arms (2)

General Anesthesia

EXPERIMENTAL

Patients who have had a stroke and meet the inclusion criteria for the study will receive general anesthesia during endovascular treatment. Choice of anesthetic for general anesthesia is dependent upon the patient condition and decision of the treating anesthesiologist (ketamine, propofol, fentanyl, midazolam,dexmedetomidine etc.). General Anesthesia Protocol: (Melinda J. Davis, Cynthia R. Campos-Herrera, \& David P. Archer, 2012; Powers et al., 2015; Talke et al., 2014). Patient will be monitored in accordance with standard monitoring guidelines and the rest of the procedure will proceed in accordance with standard of care. See Detailed Description for additional details and description of follow-up procedures.

Drug: General Anesthesia

Conscious Sedation with Remifentanil

EXPERIMENTAL

Patients who have had a stroke and meet the inclusion criteria for the study will receive conscious during endovascular treatment. Sedation will be accomplished using Remifentanil: 0.01-0.06 micrograms/kilogram/minute, titrated to effect. (Janssen et al., 2016). Patients who have had a stroke and meet the inclusion criteria for the study will receive general anesthesia during endovascular treatment. Patient will be monitored in accordance with standard monitoring guidelines and the rest of the procedure will proceed in accordance with standard of care. See Detailed Description for additional details and description of follow-up procedures.

Drug: Conscious Sedation with Remifentanil

Interventions

General Anesthesia DRUG

Patients who have had a stroke and meet the inclusion criteria for the study will receive general anesthesia during endovascular treatment. Choice of anesthetic for general anesthesia is dependent upon the patient condition and decision of the treating anesthesiologist (ketamine, propofol, fentanyl, midazolam,dexmedetomidine etc.). Induction of general anesthesia will follow standard treatment methods (Davis et al, 2012, Powers et al. 2015 Talke et al. 2015). Patient monitoring and care will proceed in accordance with standard of care guidelines. Refer to Detailed Description section for complete protocol information.

Also known as: No other names

General Anesthesia

Conscious Sedation with Remifentanil DRUG

Patients who have had a stroke and meet the inclusion criteria for the study will receive conscious during endovascular treatment. Sedation will be accomplished using Remifentanil: 0.01-0.06 micrograms/kilogram/minute, titrated to effect. (Janssen et al., 2016). Patient monitoring and care will proceed in accordance with standard of care guidelines. Refer to Detailed Description section for complete protocol information.

Also known as: No other names

Conscious Sedation with Remifentanil

Eligibility Criteria

• Age: 19 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• are greater than 18 years of age
• considered to be a candidate for endovascular therapy by the London Health Sciences Stroke team
• presenting within the first 8 hours after symptom onset EXCEPT THOSE for whom general anesthesia is thought to be clearly indicated or contraindicated, by the attending anesthesiologist.

You may not qualify if:

• Patients in whom the attending anesthesiologist considered that there was a clear indication for either GA or sedation

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Related Publications (8)

• Avitsian R, Machado SB. Anesthesia for Endovascular Approaches to Acute Ischemic Stroke. Anesthesiol Clin. 2016 Sep;34(3):497-509. doi: 10.1016/j.anclin.2016.04.004.

  PMID: 27521194 BACKGROUND

• Brinjikji W, Murad MH, Rabinstein AA, Cloft HJ, Lanzino G, Kallmes DF. Conscious sedation versus general anesthesia during endovascular acute ischemic stroke treatment: a systematic review and meta-analysis. AJNR Am J Neuroradiol. 2015 Mar;36(3):525-9. doi: 10.3174/ajnr.A4159. Epub 2014 Nov 13.

  PMID: 25395655 BACKGROUND

• Dhakal LP, Diaz-Gomez JL, Freeman WD. Role of anesthesia for endovascular treatment of ischemic stroke: do we need neurophysiological monitoring? Stroke. 2015 Jun;46(6):1748-54. doi: 10.1161/STROKEAHA.115.008223. Epub 2015 May 7. No abstract available.

  PMID: 25953376 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

• Talke PO, Sharma D, Heyer EJ, Bergese SD, Blackham KA, Stevens RD. Republished: Society for Neuroscience in Anesthesiology and Critical Care expert consensus statement: Anesthetic management of endovascular treatment for acute ischemic stroke. Stroke. 2014 Aug;45(8):e138-50. doi: 10.1161/STROKEAHA.113.003412.

  PMID: 25070964 BACKGROUND

• Janssen H, Buchholz G, Killer M, Ertl L, Bruckmann H, Lutz J. General Anesthesia Versus Conscious Sedation in Acute Stroke Treatment: The Importance of Head Immobilization. Cardiovasc Intervent Radiol. 2016 Sep;39(9):1239-44. doi: 10.1007/s00270-016-1411-5. Epub 2016 Jul 7.

  PMID: 27387186 BACKGROUND

• Sivasankar C, Stiefel M, Miano TA, Kositratna G, Yandrawatthana S, Hurst R, Kofke WA. Anesthetic variation and potential impact of anesthetics used during endovascular management of acute ischemic stroke. J Neurointerv Surg. 2016 Nov;8(11):1101-1106. doi: 10.1136/neurintsurg-2015-011998. Epub 2015 Nov 27.

  PMID: 26614493 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

MeSH Terms

Conditions

Stroke

Interventions

Anesthesia, General; Conscious Sedation; Remifentanil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Miguel Arango

  London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Miguel Arango

CONTACT

519-685-8500; miguel.arango@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor who will analyze the outcome variables for this study (consciousness, motor function, sensation, speech, coordination, standard of care follow up assessments etc.) that may be impacted by choice of anesthesia/analgesia will be blinded to the treatment group of the participants to ensure unbiased reporting.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist, Associate Professor

Model Details: There will be two arms of this study. In the first arm, the patients who meet the inclusion criteria of the study will be randomized to receive general anesthesia during endovascular treatment for stroke. In the second arm of the study, patients will receive general sedation during endovascular treatment.

Study Record Dates

• First Submitted: July 26, 2017
• First Posted: August 14, 2017
• Study Start: August 31, 2017
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: August 14, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share