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Study protocol for a randomised controlled clinical trial comparing desflurane-based versus propofol-based anaesthesia on postanaesthesia respiratory depression in patients with obstructive sleep apnoea after major abdominal surgery
INTRODUCTION: Patients with obstructive sleep apnoea (OSA) are more sensitive to postanaesthesia respiratory depression. Whether different anaesthetic regimens (intravenous-based or inhalational-based general anaesthesia) affect the postanaesthesia respiratory depression is controversial. Although d...
Autores principales: | , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8527155/ https://www.ncbi.nlm.nih.gov/pubmed/34667009 http://dx.doi.org/10.1136/bmjopen-2021-051892 |
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author | Wu, Huanghui Yang, Fei Zhang, Ran Xue, Haiyan Yang, Yongyong Liao, Ruizhe Li, Min Wu, Xiaozhi Chen, Dongsheng Chen, Guozhong Gong, Yi Hou, Lichao |
author_facet | Wu, Huanghui Yang, Fei Zhang, Ran Xue, Haiyan Yang, Yongyong Liao, Ruizhe Li, Min Wu, Xiaozhi Chen, Dongsheng Chen, Guozhong Gong, Yi Hou, Lichao |
author_sort | Wu, Huanghui |
collection | PubMed |
description | INTRODUCTION: Patients with obstructive sleep apnoea (OSA) are more sensitive to postanaesthesia respiratory depression. Whether different anaesthetic regimens (intravenous-based or inhalational-based general anaesthesia) affect the postanaesthesia respiratory depression is controversial. Although desflurane has been reported that presents favourable rapid recovery profile in special patients including whom with OSA, the strong clinical evidence of the benefit on postanaesthesia respiratory depression is far from being revealed. This study aims to fill this knowledge gap by investigating the postanaesthesia respiratory depression in postanaesthesia care unit (PACU) in patients with OSA after major abdominal surgery, followed by desflurane-based anaesthesia compared with propofol-based anaesthesia. METHODS AND ANALYSIS: Eight hundred and fifty-four patients with OSA scheduled for elective major abdominal surgery will be randomly 1:1 assigned to desflurane-based (n=427) or propofol-based anaesthesia (n=427) using a computer-generated randomisation scheme with permuted block size maintained by a centralised randomisation centre. Patients will be assessed before and a consecutive 3 days after their surgery according to the standardised tasks. Demographic data as well as surgical and anaesthesia information will be collected for the duration of the procedure. Incidence of postanaesthesia respiratory depression in PACU as well as anaesthesia recovery, emergence delirium, postoperative nausea and vomiting, rescue analgesia, duration of PACU and hospital stay, and any other adverse events will be assessed at the given study time point. Investigators performing postoperative follow-up are not involved in both anaesthesia implementation and postoperative care. ETHICS AND DISSEMINATION: This study protocol has been approved by the ethics board at Xiang’an Hospital of Xiamen University (XAHLL2019003). The results of this study will be published in a peer-review journal and presented at national conferences as poster or oral presentations. Participants wishing to know the results of this study will be contacted directly on data publication. TRIAL REGISTRATION NUMBER: ChiCTR2000031087. |
format | Online Article Text |
id | pubmed-8527155 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-85271552021-11-04 Study protocol for a randomised controlled clinical trial comparing desflurane-based versus propofol-based anaesthesia on postanaesthesia respiratory depression in patients with obstructive sleep apnoea after major abdominal surgery Wu, Huanghui Yang, Fei Zhang, Ran Xue, Haiyan Yang, Yongyong Liao, Ruizhe Li, Min Wu, Xiaozhi Chen, Dongsheng Chen, Guozhong Gong, Yi Hou, Lichao BMJ Open Anaesthesia INTRODUCTION: Patients with obstructive sleep apnoea (OSA) are more sensitive to postanaesthesia respiratory depression. Whether different anaesthetic regimens (intravenous-based or inhalational-based general anaesthesia) affect the postanaesthesia respiratory depression is controversial. Although desflurane has been reported that presents favourable rapid recovery profile in special patients including whom with OSA, the strong clinical evidence of the benefit on postanaesthesia respiratory depression is far from being revealed. This study aims to fill this knowledge gap by investigating the postanaesthesia respiratory depression in postanaesthesia care unit (PACU) in patients with OSA after major abdominal surgery, followed by desflurane-based anaesthesia compared with propofol-based anaesthesia. METHODS AND ANALYSIS: Eight hundred and fifty-four patients with OSA scheduled for elective major abdominal surgery will be randomly 1:1 assigned to desflurane-based (n=427) or propofol-based anaesthesia (n=427) using a computer-generated randomisation scheme with permuted block size maintained by a centralised randomisation centre. Patients will be assessed before and a consecutive 3 days after their surgery according to the standardised tasks. Demographic data as well as surgical and anaesthesia information will be collected for the duration of the procedure. Incidence of postanaesthesia respiratory depression in PACU as well as anaesthesia recovery, emergence delirium, postoperative nausea and vomiting, rescue analgesia, duration of PACU and hospital stay, and any other adverse events will be assessed at the given study time point. Investigators performing postoperative follow-up are not involved in both anaesthesia implementation and postoperative care. ETHICS AND DISSEMINATION: This study protocol has been approved by the ethics board at Xiang’an Hospital of Xiamen University (XAHLL2019003). The results of this study will be published in a peer-review journal and presented at national conferences as poster or oral presentations. Participants wishing to know the results of this study will be contacted directly on data publication. TRIAL REGISTRATION NUMBER: ChiCTR2000031087. BMJ Publishing Group 2021-10-19 /pmc/articles/PMC8527155/ /pubmed/34667009 http://dx.doi.org/10.1136/bmjopen-2021-051892 Text en © Author(s) (or their employer(s)) 2021. 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 Wu, Huanghui Yang, Fei Zhang, Ran Xue, Haiyan Yang, Yongyong Liao, Ruizhe Li, Min Wu, Xiaozhi Chen, Dongsheng Chen, Guozhong Gong, Yi Hou, Lichao Study protocol for a randomised controlled clinical trial comparing desflurane-based versus propofol-based anaesthesia on postanaesthesia respiratory depression in patients with obstructive sleep apnoea after major abdominal surgery |
title | Study protocol for a randomised controlled clinical trial comparing desflurane-based versus propofol-based anaesthesia on postanaesthesia respiratory depression in patients with obstructive sleep apnoea after major abdominal surgery |
title_full | Study protocol for a randomised controlled clinical trial comparing desflurane-based versus propofol-based anaesthesia on postanaesthesia respiratory depression in patients with obstructive sleep apnoea after major abdominal surgery |
title_fullStr | Study protocol for a randomised controlled clinical trial comparing desflurane-based versus propofol-based anaesthesia on postanaesthesia respiratory depression in patients with obstructive sleep apnoea after major abdominal surgery |
title_full_unstemmed | Study protocol for a randomised controlled clinical trial comparing desflurane-based versus propofol-based anaesthesia on postanaesthesia respiratory depression in patients with obstructive sleep apnoea after major abdominal surgery |
title_short | Study protocol for a randomised controlled clinical trial comparing desflurane-based versus propofol-based anaesthesia on postanaesthesia respiratory depression in patients with obstructive sleep apnoea after major abdominal surgery |
title_sort | study protocol for a randomised controlled clinical trial comparing desflurane-based versus propofol-based anaesthesia on postanaesthesia respiratory depression in patients with obstructive sleep apnoea after major abdominal surgery |
topic | Anaesthesia |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8527155/ https://www.ncbi.nlm.nih.gov/pubmed/34667009 http://dx.doi.org/10.1136/bmjopen-2021-051892 |
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