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Efficacy and Safety of Sugammadex to Shorten Time-to-Extubation Following Cardiac Surgery: A Single-Center Randomized Placebo-Controlled Trial
Residual neuromuscular blockade (NMB) is an important and modifiable factor associated with prolonged mechanical ventilation after cardiac surgery. Studies evaluating the use of sugammadex for residual NMB reversal in the post-cardiac surgery ICU setting are lacking. We conducted a randomized trial...
Autores principales: | , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Lippincott Williams & Wilkins
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9788969/ https://www.ncbi.nlm.nih.gov/pubmed/36601562 http://dx.doi.org/10.1097/CCE.0000000000000821 |
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author | Bardia, Amit Treggiari, Miriam M. Dai, Feng Johnson, Chanel Singh, Manila Kunze, Kim Tickoo, Mayanka Tantawy, Hossam Giersson, Arnar Darr, Umer Schonberger, Robert B. |
author_facet | Bardia, Amit Treggiari, Miriam M. Dai, Feng Johnson, Chanel Singh, Manila Kunze, Kim Tickoo, Mayanka Tantawy, Hossam Giersson, Arnar Darr, Umer Schonberger, Robert B. |
author_sort | Bardia, Amit |
collection | PubMed |
description | Residual neuromuscular blockade (NMB) is an important and modifiable factor associated with prolonged mechanical ventilation after cardiac surgery. Studies evaluating the use of sugammadex for residual NMB reversal in the post-cardiac surgery ICU setting are lacking. We conducted a randomized trial to determine the efficacy of sugammadex in reducing time to extubation in patients admitted to the ICU after cardiac surgery. DESIGN: Single-center, randomized, double-blind, placebo-controlled trial. SETTING: University-based cardiothoracic ICU. SUBJECTS: Patients (n = 90) undergoing elective aortic valve replacement (AVR) and/or coronary artery bypass grafting (CABG) surgery. INTERVENTIONS: Participants were randomized to receive either sugammadex (2 mg/kg) or placebo after arrival to the ICU. MEASUREMENTS AND MAIN RESULTS: The primary study endpoint was time from study drug administration to extubation. Of the 90 patients included in the study (45 in each group), a total of 68 patients underwent CABG, 13 AVR, and nine combined AVR and CABG. Baseline characteristics and intraoperative anesthetic medications were comparable between groups. Patients in sugammadex group had reduced time to extubation compared with the placebo group (median [interquartile range (IQR)]—sugammadex group: 126.0 min [84.0–274.0 min] vs placebo: 219.0 min [121.0–323.0 min]; difference in means [95% CI], 72.8 [1.5-144.1 min]; p = 0.01. There were no differences in negative inspiratory force (mean [sd]—sugammadex group: 33.79 cm H(2)O [8.39 cm H(2)O] vs placebo: –31.11 cm H(2)O [7.17 cm H(2)O]) and vital capacity (median [IQR]—sugammadex group: 1.1 L [0.9–1.3 L] vs placebo: 1.0 L [0.9–1.2 L]). There were no differences between groups in postoperative blood product requirement, dysrhythmias, length of ICU, or hospital stay. There were no serious adverse events in either group. CONCLUSIONS: This randomized trial showed that the administration of sugammadex after cardiac surgery decreased time to extubation by approximately 1 hour. Larger trials may be required to confirm these findings and determine the clinical implications. |
format | Online Article Text |
id | pubmed-9788969 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Lippincott Williams & Wilkins |
record_format | MEDLINE/PubMed |
spelling | pubmed-97889692023-01-03 Efficacy and Safety of Sugammadex to Shorten Time-to-Extubation Following Cardiac Surgery: A Single-Center Randomized Placebo-Controlled Trial Bardia, Amit Treggiari, Miriam M. Dai, Feng Johnson, Chanel Singh, Manila Kunze, Kim Tickoo, Mayanka Tantawy, Hossam Giersson, Arnar Darr, Umer Schonberger, Robert B. Crit Care Explor Original Clinical Report Residual neuromuscular blockade (NMB) is an important and modifiable factor associated with prolonged mechanical ventilation after cardiac surgery. Studies evaluating the use of sugammadex for residual NMB reversal in the post-cardiac surgery ICU setting are lacking. We conducted a randomized trial to determine the efficacy of sugammadex in reducing time to extubation in patients admitted to the ICU after cardiac surgery. DESIGN: Single-center, randomized, double-blind, placebo-controlled trial. SETTING: University-based cardiothoracic ICU. SUBJECTS: Patients (n = 90) undergoing elective aortic valve replacement (AVR) and/or coronary artery bypass grafting (CABG) surgery. INTERVENTIONS: Participants were randomized to receive either sugammadex (2 mg/kg) or placebo after arrival to the ICU. MEASUREMENTS AND MAIN RESULTS: The primary study endpoint was time from study drug administration to extubation. Of the 90 patients included in the study (45 in each group), a total of 68 patients underwent CABG, 13 AVR, and nine combined AVR and CABG. Baseline characteristics and intraoperative anesthetic medications were comparable between groups. Patients in sugammadex group had reduced time to extubation compared with the placebo group (median [interquartile range (IQR)]—sugammadex group: 126.0 min [84.0–274.0 min] vs placebo: 219.0 min [121.0–323.0 min]; difference in means [95% CI], 72.8 [1.5-144.1 min]; p = 0.01. There were no differences in negative inspiratory force (mean [sd]—sugammadex group: 33.79 cm H(2)O [8.39 cm H(2)O] vs placebo: –31.11 cm H(2)O [7.17 cm H(2)O]) and vital capacity (median [IQR]—sugammadex group: 1.1 L [0.9–1.3 L] vs placebo: 1.0 L [0.9–1.2 L]). There were no differences between groups in postoperative blood product requirement, dysrhythmias, length of ICU, or hospital stay. There were no serious adverse events in either group. CONCLUSIONS: This randomized trial showed that the administration of sugammadex after cardiac surgery decreased time to extubation by approximately 1 hour. Larger trials may be required to confirm these findings and determine the clinical implications. Lippincott Williams & Wilkins 2022-12-22 /pmc/articles/PMC9788969/ /pubmed/36601562 http://dx.doi.org/10.1097/CCE.0000000000000821 Text en Copyright © 2022 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of the Society of Critical Care Medicine. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND) (https://creativecommons.org/licenses/by-nc-nd/4.0/) , where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. |
spellingShingle | Original Clinical Report Bardia, Amit Treggiari, Miriam M. Dai, Feng Johnson, Chanel Singh, Manila Kunze, Kim Tickoo, Mayanka Tantawy, Hossam Giersson, Arnar Darr, Umer Schonberger, Robert B. Efficacy and Safety of Sugammadex to Shorten Time-to-Extubation Following Cardiac Surgery: A Single-Center Randomized Placebo-Controlled Trial |
title | Efficacy and Safety of Sugammadex to Shorten Time-to-Extubation Following Cardiac Surgery: A Single-Center Randomized Placebo-Controlled Trial |
title_full | Efficacy and Safety of Sugammadex to Shorten Time-to-Extubation Following Cardiac Surgery: A Single-Center Randomized Placebo-Controlled Trial |
title_fullStr | Efficacy and Safety of Sugammadex to Shorten Time-to-Extubation Following Cardiac Surgery: A Single-Center Randomized Placebo-Controlled Trial |
title_full_unstemmed | Efficacy and Safety of Sugammadex to Shorten Time-to-Extubation Following Cardiac Surgery: A Single-Center Randomized Placebo-Controlled Trial |
title_short | Efficacy and Safety of Sugammadex to Shorten Time-to-Extubation Following Cardiac Surgery: A Single-Center Randomized Placebo-Controlled Trial |
title_sort | efficacy and safety of sugammadex to shorten time-to-extubation following cardiac surgery: a single-center randomized placebo-controlled trial |
topic | Original Clinical Report |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9788969/ https://www.ncbi.nlm.nih.gov/pubmed/36601562 http://dx.doi.org/10.1097/CCE.0000000000000821 |
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