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Is there a difference in functional outcome at 3 months between patients who receive general anesthesia or procedural sedation during stroke thrombectomy?
In this individual patient data meta-analysis of 3 randomized clinical trials that included 368 patients with acute ischemic stroke in the anterior circulation, the use of general anesthesia during thrombectomy, compared with procedural sedation, was significantly associated with less disability at 3 months (common odds ratio for categorical shift in the modified Rankin Scale score, 1.58).
General anesthesia during thrombectomy, compared with procedural sedation, was associated with less disability at 3 months after ischemic stroke, although the findings should be interpreted tentatively because the individual trials analyzed were single-center trials and disability was the primary outcome in only 1 trial.
General anesthesia during thrombectomy for acute ischemic stroke has been associated with poor neurological outcome in nonrandomized studies. Three single-center randomized trials reported no significantly different or improved outcomes for patients who received general anesthesia compared with procedural sedation.
To detect differences in functional outcome at 3 months between patients who received general anesthesia vs procedural sedation during thrombectomy for anterior circulation acute ischemic stroke.
MEDLINE search for English-language articles published from January 1, 1980, to July 31, 2019.
Randomized clinical trials of adults with a National Institutes of Health Stroke Scale score of at least 10 and anterior circulation acute ischemic stroke assigned to receive general anesthesia or procedural sedation during thrombectomy.
Data Extraction and Synthesis
Individual patient data were obtained from 3 single-center, randomized, parallel-group, open-label treatment trials with blinded end point evaluation that met inclusion criteria and were analyzed using fixed-effects meta-analysis.
Main Outcomes and Measures
Degree of disability, measured via the modified Rankin Scale (mRS) score (range 0-6; lower scores indicate less disability), analyzed with the common odds ratio (cOR) to detect the ordinal shift in the distribution of disability over the range of mRS scores.
A total of 368 patients (mean [SD] age, 71.5 [12.9] years; 163 [44.3%] women; median [interquartile range] National Institutes of Health Stroke Scale score, 17 [14-21]) were included in the analysis, including 183 (49.7%) who received general anesthesia and 185 (50.3%) who received procedural sedation. The mean 3-month mRS score was 2.8 (95% CI, 2.5-3.1) in the general anesthesia group vs 3.2 (95% CI, 3.0-3.5) in the procedural sedation group (difference, 0.43 [95% CI, 0.03-0.83]; cOR, 1.58 [95% CI, 1.09-2.29]; P = .02). Among prespecified adverse events, only hypotension (decline in systolic blood pressure of more than 20% from baseline) (80.8% vs 53.1%; OR, 4.26 [95% CI, 2.55-7.09]; P < .001) and blood pressure variability (systolic blood pressure >180 mm Hg or <120 mm Hg) (79.7 vs 62.3%; OR, 2.42 [95% CI, 1.49-3.93]; P < .001) were significantly more common in the general anesthesia group.
Conclusions and Relevance
Among patients with acute ischemic stroke involving the anterior circulation undergoing thrombectomy, the use of protocol-based general anesthesia, compared with procedural sedation, was significantly associated with less disability at 3 months. These findings should be interpreted tentatively, given that the individual trials examined were single-center trials and disability was the primary outcome in only 1 trial.
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Corresponding Author: Julian Bösel, MD, Department of Neurology, Klinikum Kassel, Mönchebergstrasse 41-43, 34125 Kassel, Germany (firstname.lastname@example.org).
Accepted for Publication: August 20, 2019.
Correction: This article was corrected on December 20, 2019, to correct errors in the Results section regarding the absolute numbers of the secondary outcome of successful reperfusion.
Author Contributions: Drs Bösel and Schönenberger had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Drs Schönenberger, Löwhagen Hendén, Simonsen, Rasmussen, Rentzos, and Bösel contributed equally.
Concept and design: Schönenberger, Löwhagen Hendén, Simonsen, Uhlmann, Klose, Kieser, Rasmussen, Rentzos, Bösel.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Schönenberger, Uhlmann, Bösel.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Klose, Uhlmann, Kieser.
Administrative, technical, or material support: Schönenberger, Löwhagen Hendén, Simonsen, Klose, Pfaff, Sørensen, Ringleb, Wick, Möhlenbruch, Kieser, Rasmussen, Rentzos, Bösel.
Supervision: Ringleb, Wick, Möhlenbruch, Kieser, Rasmussen, Rentzos, Bösel.
Conflict of Interest Disclosures: Dr Simonsen reported receiving grants from Novo Nordisk Foundation during the conduct of the study and personal fees from Bayer and Pfizer outside the submitted work. Dr Pfaff reported receiving personal fees from Stryker and MircoVention outside the submitted work. Dr Yoo reported receiving grants from Neuravi, Penumbra, Cerenovus, Medtronic, Stryker, and Genentech and owns equity in Insera Therapeutics outside the submitted work. Dr Ringleb reported receiving personal fees from Boehringer Ingelheim, Bayer, Pfizer, Daiichi Sankyo, Covidien, and Bristol-Myers Squibb outside the submitted work. Dr Wick reported receiving research support from Appendix, Boehringer Ingelheim, Pfizer, Roche, and Vaximm. Dr Möhlenbruch reported receiving personal fees from Codman, MicroVention, Phenox, and Stryker outside the submitted work. Dr Rentzos reported receiving personal fees from Abbott Medical Sweden and I4L Innovation for Life outside the submitted work. Dr Rasmussen reported receiving a grant from the Health Research Foundation of Central Denmark Region. Dr Bösel reported receiving personal fees from Boehringer Ingelheim, Medtronic, and Zoll and support from an award from the Patient-Centered Outcomes Research Institute outside the submitted work. No other disclosures were reported.
Additional Contributions: Katrin Jensen, PhD (Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany), contributed to the statistical analysis of the trial. Jan-Erik Karlsson, MD, PhD, and Lars Rosengren, MD, PhD (Department of Neurology Sahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden), reviewed the manuscript. We also thank Niels Juul, MD (Department of Anesthesia, Aarhus, Denmark), for providing the second rating during the risk of bias assessment of the selected trials (Cochrane ROB2-tool). None of these individuals received compensation. Sherryl Sundell, BA, contributed to this article as freelancer editor with language editing. She received financial compensation for the editing.
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