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Deep versus moderate neuromuscular blockade during total hip arthroplasty to improve postoperative quality of recovery and immune function: protocol for a randomised controlled study

INTRODUCTION: There is accumulating evidence that deep neuromuscular blockade (NMB) improves intraoperative surgical conditions during laparoscopic surgery. Studies investigating the effects of deep NMB in open surgery are scarce. In theory, by limiting surgical damage through deeper muscle relaxati...

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Autores principales: Bijkerk, Veerle, Visser, Jetze, Jacobs, Lotte M C, Keijzer, Christiaan, Warlé, Michiel C
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10462972/
https://www.ncbi.nlm.nih.gov/pubmed/37640469
http://dx.doi.org/10.1136/bmjopen-2023-073537
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author Bijkerk, Veerle
Visser, Jetze
Jacobs, Lotte M C
Keijzer, Christiaan
Warlé, Michiel C
author_facet Bijkerk, Veerle
Visser, Jetze
Jacobs, Lotte M C
Keijzer, Christiaan
Warlé, Michiel C
author_sort Bijkerk, Veerle
collection PubMed
description INTRODUCTION: There is accumulating evidence that deep neuromuscular blockade (NMB) improves intraoperative surgical conditions during laparoscopic surgery. Studies investigating the effects of deep NMB in open surgery are scarce. In theory, by limiting surgical damage through deeper muscle relaxation, postoperative inflammation and concomitant immune suppression can be reduced. Therefore, this study will investigate the effects of deep NMB during total hip arthroplasty, which demands a relatively large exposure of the hip joint through and in between muscles. METHODS AND ANALYSIS: This study is a monocentre blinded randomised controlled trial in 100 patients undergoing total hip arthroplasty under general anaesthesia. Patients will be randomised in a 1:1 fashion to an intervention group of intraoperative deep NMB (a post-tetanic count of 1–2) or a control group receiving moderate NMB (a train-of-four count of 1–2). NMB will be achieved by continuous or bolus administration of rocuronium, respectively. The primary endpoint is the quality of recovery at postoperative day 1 measured by the Quality of Recovery-40 Questionnaire, analysed by Analysis of Variance. The secondary endpoint is postoperative innate immune function, measured by ex vivo production capacity of tumour necrosis factor and interleukin-1β on endotoxin stimulation of whole blood. ETHICS AND DISSEMINATION: Ethical approval for this study was granted by the Medical Ethics Committee ‘METC Oost-Nederland’ (reference number 2022-15754). Informed consent will be obtained prior to study participation. Study results will be published in an international peer-reviewed journal. TRIAL REGISTRATION NUMBERS: ClinicalTrials.gov Registry (NCT05562999) and EudraCT Registry (2022-002451-19).
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spelling pubmed-104629722023-08-30 Deep versus moderate neuromuscular blockade during total hip arthroplasty to improve postoperative quality of recovery and immune function: protocol for a randomised controlled study Bijkerk, Veerle Visser, Jetze Jacobs, Lotte M C Keijzer, Christiaan Warlé, Michiel C BMJ Open Anaesthesia INTRODUCTION: There is accumulating evidence that deep neuromuscular blockade (NMB) improves intraoperative surgical conditions during laparoscopic surgery. Studies investigating the effects of deep NMB in open surgery are scarce. In theory, by limiting surgical damage through deeper muscle relaxation, postoperative inflammation and concomitant immune suppression can be reduced. Therefore, this study will investigate the effects of deep NMB during total hip arthroplasty, which demands a relatively large exposure of the hip joint through and in between muscles. METHODS AND ANALYSIS: This study is a monocentre blinded randomised controlled trial in 100 patients undergoing total hip arthroplasty under general anaesthesia. Patients will be randomised in a 1:1 fashion to an intervention group of intraoperative deep NMB (a post-tetanic count of 1–2) or a control group receiving moderate NMB (a train-of-four count of 1–2). NMB will be achieved by continuous or bolus administration of rocuronium, respectively. The primary endpoint is the quality of recovery at postoperative day 1 measured by the Quality of Recovery-40 Questionnaire, analysed by Analysis of Variance. The secondary endpoint is postoperative innate immune function, measured by ex vivo production capacity of tumour necrosis factor and interleukin-1β on endotoxin stimulation of whole blood. ETHICS AND DISSEMINATION: Ethical approval for this study was granted by the Medical Ethics Committee ‘METC Oost-Nederland’ (reference number 2022-15754). Informed consent will be obtained prior to study participation. Study results will be published in an international peer-reviewed journal. TRIAL REGISTRATION NUMBERS: ClinicalTrials.gov Registry (NCT05562999) and EudraCT Registry (2022-002451-19). BMJ Publishing Group 2023-08-28 /pmc/articles/PMC10462972/ /pubmed/37640469 http://dx.doi.org/10.1136/bmjopen-2023-073537 Text en © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Anaesthesia
Bijkerk, Veerle
Visser, Jetze
Jacobs, Lotte M C
Keijzer, Christiaan
Warlé, Michiel C
Deep versus moderate neuromuscular blockade during total hip arthroplasty to improve postoperative quality of recovery and immune function: protocol for a randomised controlled study
title Deep versus moderate neuromuscular blockade during total hip arthroplasty to improve postoperative quality of recovery and immune function: protocol for a randomised controlled study
title_full Deep versus moderate neuromuscular blockade during total hip arthroplasty to improve postoperative quality of recovery and immune function: protocol for a randomised controlled study
title_fullStr Deep versus moderate neuromuscular blockade during total hip arthroplasty to improve postoperative quality of recovery and immune function: protocol for a randomised controlled study
title_full_unstemmed Deep versus moderate neuromuscular blockade during total hip arthroplasty to improve postoperative quality of recovery and immune function: protocol for a randomised controlled study
title_short Deep versus moderate neuromuscular blockade during total hip arthroplasty to improve postoperative quality of recovery and immune function: protocol for a randomised controlled study
title_sort deep versus moderate neuromuscular blockade during total hip arthroplasty to improve postoperative quality of recovery and immune function: protocol for a randomised controlled study
topic Anaesthesia
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10462972/
https://www.ncbi.nlm.nih.gov/pubmed/37640469
http://dx.doi.org/10.1136/bmjopen-2023-073537
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