Sugammadex, neostigmine and postoperative pulmonary complications: an international randomised feasibility and pilot trial

Abstract Background Sugammadex reduces residual neuromuscular blockade after anaesthesia, potentially preventing postoperative pulmonary complications. However, definitive evidence is lacking. We therefore conducted a feasibility and pilot trial for a large randomised controlled trial of sugammadex,...

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Autores principales:	Kate Leslie, Matthew T. V. Chan, Jai N. Darvall, Anurika P. De Silva, Sabine Braat, Nancy J. Devlin, Philip J. Peyton, Jade Radnor, Carmen K. M. Lam, Sofia Sidiropoulos, David A. Story
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Sugammadex Neostigmine Neuromuscular blockade Atelectasis Pneumonia Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/0b47a331b2e041a09913c75a80d34146
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spelling	oai:doaj.org-article:0b47a331b2e041a09913c75a80d341462021-11-14T12:12:39ZSugammadex, neostigmine and postoperative pulmonary complications: an international randomised feasibility and pilot trial10.1186/s40814-021-00942-92055-5784https://doaj.org/article/0b47a331b2e041a09913c75a80d341462021-11-01T00:00:00Zhttps://doi.org/10.1186/s40814-021-00942-9https://doaj.org/toc/2055-5784Abstract Background Sugammadex reduces residual neuromuscular blockade after anaesthesia, potentially preventing postoperative pulmonary complications. However, definitive evidence is lacking. We therefore conducted a feasibility and pilot trial for a large randomised controlled trial of sugammadex, neostigmine, and postoperative pulmonary complications. Methods Patients aged ≥40 years having elective or expedited abdominal or intrathoracic surgery were recruited in Australia and Hong Kong. Perioperative care was at the discretion of clinicians, except for the use of rocuronium and/or vecuronium for neuromuscular blockade and the randomised intervention (sugammadex or neostigmine) for reversal. Feasibility measurements included recruitment, crossover, acceptability, completeness, and workload. Trial coordinator feedback was systematically sought. Patient-reported quality of life was measured using the EQ-5D-5L score. The primary pilot outcome was the incidence of new pulmonary complications up to hospital discharge (or postoperative day 7 if still in hospital). Results Among 150 eligible patients, 120 consented to participate (recruitment rate 80%, 95% confidence interval [CI] 73 to 86%). The randomised intervention was administered without crossover to 115 of 117 patients who received reversal (98%, 95% CI 94 to 100%). The protocol was acceptable or highly acceptable to the anaesthetist in 108 of 116 cases (93%, 95% CI 87 to 97%; missing = 4). Four patients of the 120 patients were lost to follow-up at 3 months (3.3%, 95% CI 0.9 to 8.3%). Case report forms were complete at 3 months for all remaining patients. The median time to complete trial processes was 3.5 h (range 2.5–4.5 h). Trial coordinators reported no barriers to trial processes. Patients were aged 64 (standard deviation 11) years, 70 (58%) were male and 50 (42%) were female, and planned surgeries were thoracic (23 [19%]), upper abdominal (41 [34%]), and lower abdominal (56 [47%]). The primary outcome was observed in 5 (8.5%) of the 59 sugammadex patients and 5 (8.2%) of the 61 neostigmine patients (odds ratio 1.02, 95% CI 0.28 to 3.67). Conclusions A large international randomised controlled trial of sugammadex, neostigmine and postoperative pulmonary complications in adult patients having abdominal and intrathoracic surgery, including collection of cost-effectiveness evidence for Health Technology Appraisal, is feasible. Trial registration Prospectively registered at the Australian and New Zealand Clinical Trials Registry ( ACTRN12620001313921 ) on December 7, 2020. www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380645&isReview=true .Kate LeslieMatthew T. V. ChanJai N. DarvallAnurika P. De SilvaSabine BraatNancy J. DevlinPhilip J. PeytonJade RadnorCarmen K. M. LamSofia SidiropoulosDavid A. StoryBMCarticleSugammadexNeostigmineNeuromuscular blockadeAtelectasisPneumoniaMedicine (General)R5-920ENPilot and Feasibility Studies, Vol 7, Iss 1, Pp 1-11 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Sugammadex Neostigmine Neuromuscular blockade Atelectasis Pneumonia Medicine (General) R5-920
spellingShingle	Sugammadex Neostigmine Neuromuscular blockade Atelectasis Pneumonia Medicine (General) R5-920 Kate Leslie Matthew T. V. Chan Jai N. Darvall Anurika P. De Silva Sabine Braat Nancy J. Devlin Philip J. Peyton Jade Radnor Carmen K. M. Lam Sofia Sidiropoulos David A. Story Sugammadex, neostigmine and postoperative pulmonary complications: an international randomised feasibility and pilot trial
description	Abstract Background Sugammadex reduces residual neuromuscular blockade after anaesthesia, potentially preventing postoperative pulmonary complications. However, definitive evidence is lacking. We therefore conducted a feasibility and pilot trial for a large randomised controlled trial of sugammadex, neostigmine, and postoperative pulmonary complications. Methods Patients aged ≥40 years having elective or expedited abdominal or intrathoracic surgery were recruited in Australia and Hong Kong. Perioperative care was at the discretion of clinicians, except for the use of rocuronium and/or vecuronium for neuromuscular blockade and the randomised intervention (sugammadex or neostigmine) for reversal. Feasibility measurements included recruitment, crossover, acceptability, completeness, and workload. Trial coordinator feedback was systematically sought. Patient-reported quality of life was measured using the EQ-5D-5L score. The primary pilot outcome was the incidence of new pulmonary complications up to hospital discharge (or postoperative day 7 if still in hospital). Results Among 150 eligible patients, 120 consented to participate (recruitment rate 80%, 95% confidence interval [CI] 73 to 86%). The randomised intervention was administered without crossover to 115 of 117 patients who received reversal (98%, 95% CI 94 to 100%). The protocol was acceptable or highly acceptable to the anaesthetist in 108 of 116 cases (93%, 95% CI 87 to 97%; missing = 4). Four patients of the 120 patients were lost to follow-up at 3 months (3.3%, 95% CI 0.9 to 8.3%). Case report forms were complete at 3 months for all remaining patients. The median time to complete trial processes was 3.5 h (range 2.5–4.5 h). Trial coordinators reported no barriers to trial processes. Patients were aged 64 (standard deviation 11) years, 70 (58%) were male and 50 (42%) were female, and planned surgeries were thoracic (23 [19%]), upper abdominal (41 [34%]), and lower abdominal (56 [47%]). The primary outcome was observed in 5 (8.5%) of the 59 sugammadex patients and 5 (8.2%) of the 61 neostigmine patients (odds ratio 1.02, 95% CI 0.28 to 3.67). Conclusions A large international randomised controlled trial of sugammadex, neostigmine and postoperative pulmonary complications in adult patients having abdominal and intrathoracic surgery, including collection of cost-effectiveness evidence for Health Technology Appraisal, is feasible. Trial registration Prospectively registered at the Australian and New Zealand Clinical Trials Registry ( ACTRN12620001313921 ) on December 7, 2020. www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380645&isReview=true .
format	article
author	Kate Leslie Matthew T. V. Chan Jai N. Darvall Anurika P. De Silva Sabine Braat Nancy J. Devlin Philip J. Peyton Jade Radnor Carmen K. M. Lam Sofia Sidiropoulos David A. Story
author_facet	Kate Leslie Matthew T. V. Chan Jai N. Darvall Anurika P. De Silva Sabine Braat Nancy J. Devlin Philip J. Peyton Jade Radnor Carmen K. M. Lam Sofia Sidiropoulos David A. Story
author_sort	Kate Leslie
title	Sugammadex, neostigmine and postoperative pulmonary complications: an international randomised feasibility and pilot trial
title_short	Sugammadex, neostigmine and postoperative pulmonary complications: an international randomised feasibility and pilot trial
title_full	Sugammadex, neostigmine and postoperative pulmonary complications: an international randomised feasibility and pilot trial
title_fullStr	Sugammadex, neostigmine and postoperative pulmonary complications: an international randomised feasibility and pilot trial
title_full_unstemmed	Sugammadex, neostigmine and postoperative pulmonary complications: an international randomised feasibility and pilot trial
title_sort	sugammadex, neostigmine and postoperative pulmonary complications: an international randomised feasibility and pilot trial
publisher	BMC
publishDate	2021
url	https://doaj.org/article/0b47a331b2e041a09913c75a80d34146
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Sugammadex, neostigmine and postoperative pulmonary complications: an international randomised feasibility and pilot trial

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