Effectiveness of general anaesthesia with remimazolam tosilate on intraoperative haemodynamics and postoperative recovery: study protocol for a randomised, positive-controlled, pragmatic clinical trial (GARTH trial)

Introduction It is encouraged to estimate the effectiveness of components within the enhanced recovery after surgery (ERAS) protocol through patient-reported outcomes, alongside doctor-reported outcomes and length of hospital stay. At present, studies on the contributions of optimal anaesthetic drugs within the ERAS protocol to patient-reported and doctor-reported outcomes are limited. Therefore, this study aims to pragmatically evaluate the effectiveness and safety of general anaesthesia (GA) with remimazolam tosilate within the ERAS protocol on intraoperative haemodynamics and postoperative recovery in adults undergoing elective surgeries, compared with propofol.Methods and analysis This study is a single-centre, randomised, blinded, positive-controlled, pragmatic clinical trial. A total of 900 patients, aged ≥18 years old, scheduled for an elective surgical procedure under GA will be included. Patients will be randomised in a 1:1 ratio to the remimazolam group (the GA with remimazolam tosilate within the ERAS protocol group) or propofol group (the GA with propofol within the ERAS protocol group), stratified by general surgery, thoracic surgery and other surgeries (including urological surgery and otolaryngology surgery). The primary outcomes include the 24-hour postoperative quality of recovery-40 score and the rate of intraoperative hypotension. Secondary endpoints include the rate of sedative hypotension requiring treatment, the haemodynamic profiles, the 72-hour postoperative quality of recovery-40 score, the functional anaesthetic capability, adverse events and complications, quality of life within 3 months as well as economic health outcomes.Ethics and dissemination This study protocol has been approved by the ethics committee of Guangdong Provincial People’s Hospital (KY-H-2022-005-03-08). Dissemination plans will be presented at scientific meetings and in scientific publications.Trial registration number ChiCTR2200062520 Ausführliche Beschreibung

Gespeichert in:

Autor*in:	Fei Zhong [verfasserIn] Changyin Lu [verfasserIn] Yin Kang [verfasserIn] Quehua Luo [verfasserIn] Yujing Cai [verfasserIn] Guangyan Zhang [verfasserIn] Zhimin Guo [verfasserIn] Shaoting Zhang [verfasserIn] Jue Ma [verfasserIn] HaiHua Shu [verfasserIn]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2024

Übergeordnetes Werk:	In: BMJ Open - BMJ Publishing Group, 2011, 14(2024), 1
Übergeordnetes Werk:	volume:14 ; year:2024 ; number:1

Links:	Link aufrufen Link aufrufen Link aufrufen Journal toc

DOI / URN:	10.1136/bmjopen-2023-073024

Katalog-ID:	DOAJ097028657

Internformat


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allfields	10.1136/bmjopen-2023-073024 doi (DE-627)DOAJ097028657 (DE-599)DOAJ4dc352f589484231955f2e960f0b0afd DE-627 ger DE-627 rakwb eng Fei Zhong verfasserin aut Effectiveness of general anaesthesia with remimazolam tosilate on intraoperative haemodynamics and postoperative recovery: study protocol for a randomised, positive-controlled, pragmatic clinical trial (GARTH trial) 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Introduction It is encouraged to estimate the effectiveness of components within the enhanced recovery after surgery (ERAS) protocol through patient-reported outcomes, alongside doctor-reported outcomes and length of hospital stay. At present, studies on the contributions of optimal anaesthetic drugs within the ERAS protocol to patient-reported and doctor-reported outcomes are limited. Therefore, this study aims to pragmatically evaluate the effectiveness and safety of general anaesthesia (GA) with remimazolam tosilate within the ERAS protocol on intraoperative haemodynamics and postoperative recovery in adults undergoing elective surgeries, compared with propofol.Methods and analysis This study is a single-centre, randomised, blinded, positive-controlled, pragmatic clinical trial. A total of 900 patients, aged ≥18 years old, scheduled for an elective surgical procedure under GA will be included. Patients will be randomised in a 1:1 ratio to the remimazolam group (the GA with remimazolam tosilate within the ERAS protocol group) or propofol group (the GA with propofol within the ERAS protocol group), stratified by general surgery, thoracic surgery and other surgeries (including urological surgery and otolaryngology surgery). The primary outcomes include the 24-hour postoperative quality of recovery-40 score and the rate of intraoperative hypotension. Secondary endpoints include the rate of sedative hypotension requiring treatment, the haemodynamic profiles, the 72-hour postoperative quality of recovery-40 score, the functional anaesthetic capability, adverse events and complications, quality of life within 3 months as well as economic health outcomes.Ethics and dissemination This study protocol has been approved by the ethics committee of Guangdong Provincial People’s Hospital (KY-H-2022-005-03-08). Dissemination plans will be presented at scientific meetings and in scientific publications.Trial registration number ChiCTR2200062520 Medicine R Changyin Lu verfasserin aut Yin Kang verfasserin aut Quehua Luo verfasserin aut Yujing Cai verfasserin aut Guangyan Zhang verfasserin aut Zhimin Guo verfasserin aut Shaoting Zhang verfasserin aut Jue Ma verfasserin aut HaiHua Shu verfasserin aut In BMJ Open BMJ Publishing Group, 2011 14(2024), 1 (DE-627)654747075 (DE-600)2599832-8 20446055 nnns volume:14 year:2024 number:1 https://doi.org/10.1136/bmjopen-2023-073024 kostenfrei https://doaj.org/article/4dc352f589484231955f2e960f0b0afd kostenfrei https://bmjopen.bmj.com/content/14/1/e073024.full kostenfrei https://doaj.org/toc/2044-6055 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_375 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 14 2024 1
spelling	10.1136/bmjopen-2023-073024 doi (DE-627)DOAJ097028657 (DE-599)DOAJ4dc352f589484231955f2e960f0b0afd DE-627 ger DE-627 rakwb eng Fei Zhong verfasserin aut Effectiveness of general anaesthesia with remimazolam tosilate on intraoperative haemodynamics and postoperative recovery: study protocol for a randomised, positive-controlled, pragmatic clinical trial (GARTH trial) 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Introduction It is encouraged to estimate the effectiveness of components within the enhanced recovery after surgery (ERAS) protocol through patient-reported outcomes, alongside doctor-reported outcomes and length of hospital stay. At present, studies on the contributions of optimal anaesthetic drugs within the ERAS protocol to patient-reported and doctor-reported outcomes are limited. Therefore, this study aims to pragmatically evaluate the effectiveness and safety of general anaesthesia (GA) with remimazolam tosilate within the ERAS protocol on intraoperative haemodynamics and postoperative recovery in adults undergoing elective surgeries, compared with propofol.Methods and analysis This study is a single-centre, randomised, blinded, positive-controlled, pragmatic clinical trial. A total of 900 patients, aged ≥18 years old, scheduled for an elective surgical procedure under GA will be included. Patients will be randomised in a 1:1 ratio to the remimazolam group (the GA with remimazolam tosilate within the ERAS protocol group) or propofol group (the GA with propofol within the ERAS protocol group), stratified by general surgery, thoracic surgery and other surgeries (including urological surgery and otolaryngology surgery). The primary outcomes include the 24-hour postoperative quality of recovery-40 score and the rate of intraoperative hypotension. Secondary endpoints include the rate of sedative hypotension requiring treatment, the haemodynamic profiles, the 72-hour postoperative quality of recovery-40 score, the functional anaesthetic capability, adverse events and complications, quality of life within 3 months as well as economic health outcomes.Ethics and dissemination This study protocol has been approved by the ethics committee of Guangdong Provincial People’s Hospital (KY-H-2022-005-03-08). Dissemination plans will be presented at scientific meetings and in scientific publications.Trial registration number ChiCTR2200062520 Medicine R Changyin Lu verfasserin aut Yin Kang verfasserin aut Quehua Luo verfasserin aut Yujing Cai verfasserin aut Guangyan Zhang verfasserin aut Zhimin Guo verfasserin aut Shaoting Zhang verfasserin aut Jue Ma verfasserin aut HaiHua Shu verfasserin aut In BMJ Open BMJ Publishing Group, 2011 14(2024), 1 (DE-627)654747075 (DE-600)2599832-8 20446055 nnns volume:14 year:2024 number:1 https://doi.org/10.1136/bmjopen-2023-073024 kostenfrei https://doaj.org/article/4dc352f589484231955f2e960f0b0afd kostenfrei https://bmjopen.bmj.com/content/14/1/e073024.full kostenfrei https://doaj.org/toc/2044-6055 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_375 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 14 2024 1
allfields_unstemmed	10.1136/bmjopen-2023-073024 doi (DE-627)DOAJ097028657 (DE-599)DOAJ4dc352f589484231955f2e960f0b0afd DE-627 ger DE-627 rakwb eng Fei Zhong verfasserin aut Effectiveness of general anaesthesia with remimazolam tosilate on intraoperative haemodynamics and postoperative recovery: study protocol for a randomised, positive-controlled, pragmatic clinical trial (GARTH trial) 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Introduction It is encouraged to estimate the effectiveness of components within the enhanced recovery after surgery (ERAS) protocol through patient-reported outcomes, alongside doctor-reported outcomes and length of hospital stay. At present, studies on the contributions of optimal anaesthetic drugs within the ERAS protocol to patient-reported and doctor-reported outcomes are limited. Therefore, this study aims to pragmatically evaluate the effectiveness and safety of general anaesthesia (GA) with remimazolam tosilate within the ERAS protocol on intraoperative haemodynamics and postoperative recovery in adults undergoing elective surgeries, compared with propofol.Methods and analysis This study is a single-centre, randomised, blinded, positive-controlled, pragmatic clinical trial. A total of 900 patients, aged ≥18 years old, scheduled for an elective surgical procedure under GA will be included. Patients will be randomised in a 1:1 ratio to the remimazolam group (the GA with remimazolam tosilate within the ERAS protocol group) or propofol group (the GA with propofol within the ERAS protocol group), stratified by general surgery, thoracic surgery and other surgeries (including urological surgery and otolaryngology surgery). The primary outcomes include the 24-hour postoperative quality of recovery-40 score and the rate of intraoperative hypotension. Secondary endpoints include the rate of sedative hypotension requiring treatment, the haemodynamic profiles, the 72-hour postoperative quality of recovery-40 score, the functional anaesthetic capability, adverse events and complications, quality of life within 3 months as well as economic health outcomes.Ethics and dissemination This study protocol has been approved by the ethics committee of Guangdong Provincial People’s Hospital (KY-H-2022-005-03-08). Dissemination plans will be presented at scientific meetings and in scientific publications.Trial registration number ChiCTR2200062520 Medicine R Changyin Lu verfasserin aut Yin Kang verfasserin aut Quehua Luo verfasserin aut Yujing Cai verfasserin aut Guangyan Zhang verfasserin aut Zhimin Guo verfasserin aut Shaoting Zhang verfasserin aut Jue Ma verfasserin aut HaiHua Shu verfasserin aut In BMJ Open BMJ Publishing Group, 2011 14(2024), 1 (DE-627)654747075 (DE-600)2599832-8 20446055 nnns volume:14 year:2024 number:1 https://doi.org/10.1136/bmjopen-2023-073024 kostenfrei https://doaj.org/article/4dc352f589484231955f2e960f0b0afd kostenfrei https://bmjopen.bmj.com/content/14/1/e073024.full kostenfrei https://doaj.org/toc/2044-6055 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_375 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 14 2024 1
allfieldsGer	10.1136/bmjopen-2023-073024 doi (DE-627)DOAJ097028657 (DE-599)DOAJ4dc352f589484231955f2e960f0b0afd DE-627 ger DE-627 rakwb eng Fei Zhong verfasserin aut Effectiveness of general anaesthesia with remimazolam tosilate on intraoperative haemodynamics and postoperative recovery: study protocol for a randomised, positive-controlled, pragmatic clinical trial (GARTH trial) 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Introduction It is encouraged to estimate the effectiveness of components within the enhanced recovery after surgery (ERAS) protocol through patient-reported outcomes, alongside doctor-reported outcomes and length of hospital stay. At present, studies on the contributions of optimal anaesthetic drugs within the ERAS protocol to patient-reported and doctor-reported outcomes are limited. Therefore, this study aims to pragmatically evaluate the effectiveness and safety of general anaesthesia (GA) with remimazolam tosilate within the ERAS protocol on intraoperative haemodynamics and postoperative recovery in adults undergoing elective surgeries, compared with propofol.Methods and analysis This study is a single-centre, randomised, blinded, positive-controlled, pragmatic clinical trial. A total of 900 patients, aged ≥18 years old, scheduled for an elective surgical procedure under GA will be included. Patients will be randomised in a 1:1 ratio to the remimazolam group (the GA with remimazolam tosilate within the ERAS protocol group) or propofol group (the GA with propofol within the ERAS protocol group), stratified by general surgery, thoracic surgery and other surgeries (including urological surgery and otolaryngology surgery). The primary outcomes include the 24-hour postoperative quality of recovery-40 score and the rate of intraoperative hypotension. Secondary endpoints include the rate of sedative hypotension requiring treatment, the haemodynamic profiles, the 72-hour postoperative quality of recovery-40 score, the functional anaesthetic capability, adverse events and complications, quality of life within 3 months as well as economic health outcomes.Ethics and dissemination This study protocol has been approved by the ethics committee of Guangdong Provincial People’s Hospital (KY-H-2022-005-03-08). Dissemination plans will be presented at scientific meetings and in scientific publications.Trial registration number ChiCTR2200062520 Medicine R Changyin Lu verfasserin aut Yin Kang verfasserin aut Quehua Luo verfasserin aut Yujing Cai verfasserin aut Guangyan Zhang verfasserin aut Zhimin Guo verfasserin aut Shaoting Zhang verfasserin aut Jue Ma verfasserin aut HaiHua Shu verfasserin aut In BMJ Open BMJ Publishing Group, 2011 14(2024), 1 (DE-627)654747075 (DE-600)2599832-8 20446055 nnns volume:14 year:2024 number:1 https://doi.org/10.1136/bmjopen-2023-073024 kostenfrei https://doaj.org/article/4dc352f589484231955f2e960f0b0afd kostenfrei https://bmjopen.bmj.com/content/14/1/e073024.full kostenfrei https://doaj.org/toc/2044-6055 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_375 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 14 2024 1
allfieldsSound	10.1136/bmjopen-2023-073024 doi (DE-627)DOAJ097028657 (DE-599)DOAJ4dc352f589484231955f2e960f0b0afd DE-627 ger DE-627 rakwb eng Fei Zhong verfasserin aut Effectiveness of general anaesthesia with remimazolam tosilate on intraoperative haemodynamics and postoperative recovery: study protocol for a randomised, positive-controlled, pragmatic clinical trial (GARTH trial) 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Introduction It is encouraged to estimate the effectiveness of components within the enhanced recovery after surgery (ERAS) protocol through patient-reported outcomes, alongside doctor-reported outcomes and length of hospital stay. At present, studies on the contributions of optimal anaesthetic drugs within the ERAS protocol to patient-reported and doctor-reported outcomes are limited. Therefore, this study aims to pragmatically evaluate the effectiveness and safety of general anaesthesia (GA) with remimazolam tosilate within the ERAS protocol on intraoperative haemodynamics and postoperative recovery in adults undergoing elective surgeries, compared with propofol.Methods and analysis This study is a single-centre, randomised, blinded, positive-controlled, pragmatic clinical trial. A total of 900 patients, aged ≥18 years old, scheduled for an elective surgical procedure under GA will be included. Patients will be randomised in a 1:1 ratio to the remimazolam group (the GA with remimazolam tosilate within the ERAS protocol group) or propofol group (the GA with propofol within the ERAS protocol group), stratified by general surgery, thoracic surgery and other surgeries (including urological surgery and otolaryngology surgery). The primary outcomes include the 24-hour postoperative quality of recovery-40 score and the rate of intraoperative hypotension. Secondary endpoints include the rate of sedative hypotension requiring treatment, the haemodynamic profiles, the 72-hour postoperative quality of recovery-40 score, the functional anaesthetic capability, adverse events and complications, quality of life within 3 months as well as economic health outcomes.Ethics and dissemination This study protocol has been approved by the ethics committee of Guangdong Provincial People’s Hospital (KY-H-2022-005-03-08). Dissemination plans will be presented at scientific meetings and in scientific publications.Trial registration number ChiCTR2200062520 Medicine R Changyin Lu verfasserin aut Yin Kang verfasserin aut Quehua Luo verfasserin aut Yujing Cai verfasserin aut Guangyan Zhang verfasserin aut Zhimin Guo verfasserin aut Shaoting Zhang verfasserin aut Jue Ma verfasserin aut HaiHua Shu verfasserin aut In BMJ Open BMJ Publishing Group, 2011 14(2024), 1 (DE-627)654747075 (DE-600)2599832-8 20446055 nnns volume:14 year:2024 number:1 https://doi.org/10.1136/bmjopen-2023-073024 kostenfrei https://doaj.org/article/4dc352f589484231955f2e960f0b0afd kostenfrei https://bmjopen.bmj.com/content/14/1/e073024.full kostenfrei https://doaj.org/toc/2044-6055 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_375 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 14 2024 1
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title	Effectiveness of general anaesthesia with remimazolam tosilate on intraoperative haemodynamics and postoperative recovery: study protocol for a randomised, positive-controlled, pragmatic clinical trial (GARTH trial)
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author_browse	Fei Zhong Changyin Lu Yin Kang Quehua Luo Yujing Cai Guangyan Zhang Zhimin Guo Shaoting Zhang Jue Ma HaiHua Shu
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title_sort	effectiveness of general anaesthesia with remimazolam tosilate on intraoperative haemodynamics and postoperative recovery: study protocol for a randomised, positive-controlled, pragmatic clinical trial (garth trial)
title_auth	Effectiveness of general anaesthesia with remimazolam tosilate on intraoperative haemodynamics and postoperative recovery: study protocol for a randomised, positive-controlled, pragmatic clinical trial (GARTH trial)
abstract	Introduction It is encouraged to estimate the effectiveness of components within the enhanced recovery after surgery (ERAS) protocol through patient-reported outcomes, alongside doctor-reported outcomes and length of hospital stay. At present, studies on the contributions of optimal anaesthetic drugs within the ERAS protocol to patient-reported and doctor-reported outcomes are limited. Therefore, this study aims to pragmatically evaluate the effectiveness and safety of general anaesthesia (GA) with remimazolam tosilate within the ERAS protocol on intraoperative haemodynamics and postoperative recovery in adults undergoing elective surgeries, compared with propofol.Methods and analysis This study is a single-centre, randomised, blinded, positive-controlled, pragmatic clinical trial. A total of 900 patients, aged ≥18 years old, scheduled for an elective surgical procedure under GA will be included. Patients will be randomised in a 1:1 ratio to the remimazolam group (the GA with remimazolam tosilate within the ERAS protocol group) or propofol group (the GA with propofol within the ERAS protocol group), stratified by general surgery, thoracic surgery and other surgeries (including urological surgery and otolaryngology surgery). The primary outcomes include the 24-hour postoperative quality of recovery-40 score and the rate of intraoperative hypotension. Secondary endpoints include the rate of sedative hypotension requiring treatment, the haemodynamic profiles, the 72-hour postoperative quality of recovery-40 score, the functional anaesthetic capability, adverse events and complications, quality of life within 3 months as well as economic health outcomes.Ethics and dissemination This study protocol has been approved by the ethics committee of Guangdong Provincial People’s Hospital (KY-H-2022-005-03-08). Dissemination plans will be presented at scientific meetings and in scientific publications.Trial registration number ChiCTR2200062520
abstractGer	Introduction It is encouraged to estimate the effectiveness of components within the enhanced recovery after surgery (ERAS) protocol through patient-reported outcomes, alongside doctor-reported outcomes and length of hospital stay. At present, studies on the contributions of optimal anaesthetic drugs within the ERAS protocol to patient-reported and doctor-reported outcomes are limited. Therefore, this study aims to pragmatically evaluate the effectiveness and safety of general anaesthesia (GA) with remimazolam tosilate within the ERAS protocol on intraoperative haemodynamics and postoperative recovery in adults undergoing elective surgeries, compared with propofol.Methods and analysis This study is a single-centre, randomised, blinded, positive-controlled, pragmatic clinical trial. A total of 900 patients, aged ≥18 years old, scheduled for an elective surgical procedure under GA will be included. Patients will be randomised in a 1:1 ratio to the remimazolam group (the GA with remimazolam tosilate within the ERAS protocol group) or propofol group (the GA with propofol within the ERAS protocol group), stratified by general surgery, thoracic surgery and other surgeries (including urological surgery and otolaryngology surgery). The primary outcomes include the 24-hour postoperative quality of recovery-40 score and the rate of intraoperative hypotension. Secondary endpoints include the rate of sedative hypotension requiring treatment, the haemodynamic profiles, the 72-hour postoperative quality of recovery-40 score, the functional anaesthetic capability, adverse events and complications, quality of life within 3 months as well as economic health outcomes.Ethics and dissemination This study protocol has been approved by the ethics committee of Guangdong Provincial People’s Hospital (KY-H-2022-005-03-08). Dissemination plans will be presented at scientific meetings and in scientific publications.Trial registration number ChiCTR2200062520
abstract_unstemmed	Introduction It is encouraged to estimate the effectiveness of components within the enhanced recovery after surgery (ERAS) protocol through patient-reported outcomes, alongside doctor-reported outcomes and length of hospital stay. At present, studies on the contributions of optimal anaesthetic drugs within the ERAS protocol to patient-reported and doctor-reported outcomes are limited. Therefore, this study aims to pragmatically evaluate the effectiveness and safety of general anaesthesia (GA) with remimazolam tosilate within the ERAS protocol on intraoperative haemodynamics and postoperative recovery in adults undergoing elective surgeries, compared with propofol.Methods and analysis This study is a single-centre, randomised, blinded, positive-controlled, pragmatic clinical trial. A total of 900 patients, aged ≥18 years old, scheduled for an elective surgical procedure under GA will be included. Patients will be randomised in a 1:1 ratio to the remimazolam group (the GA with remimazolam tosilate within the ERAS protocol group) or propofol group (the GA with propofol within the ERAS protocol group), stratified by general surgery, thoracic surgery and other surgeries (including urological surgery and otolaryngology surgery). The primary outcomes include the 24-hour postoperative quality of recovery-40 score and the rate of intraoperative hypotension. Secondary endpoints include the rate of sedative hypotension requiring treatment, the haemodynamic profiles, the 72-hour postoperative quality of recovery-40 score, the functional anaesthetic capability, adverse events and complications, quality of life within 3 months as well as economic health outcomes.Ethics and dissemination This study protocol has been approved by the ethics committee of Guangdong Provincial People’s Hospital (KY-H-2022-005-03-08). Dissemination plans will be presented at scientific meetings and in scientific publications.Trial registration number ChiCTR2200062520
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title_short	Effectiveness of general anaesthesia with remimazolam tosilate on intraoperative haemodynamics and postoperative recovery: study protocol for a randomised, positive-controlled, pragmatic clinical trial (GARTH trial)
url	https://doi.org/10.1136/bmjopen-2023-073024 https://doaj.org/article/4dc352f589484231955f2e960f0b0afd https://bmjopen.bmj.com/content/14/1/e073024.full https://doaj.org/toc/2044-6055
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author2	Changyin Lu Yin Kang Quehua Luo Yujing Cai Guangyan Zhang Zhimin Guo Shaoting Zhang Jue Ma HaiHua Shu
author2Str	Changyin Lu Yin Kang Quehua Luo Yujing Cai Guangyan Zhang Zhimin Guo Shaoting Zhang Jue Ma HaiHua Shu
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up_date	2024-07-03T23:27:52.877Z
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