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Acupuncture-assisted anaesthesia for catheter ablation of atrial fibrillation to reduce the consumption of morphine hydrochloride and postoperative nausea and vomiting (PONV): study protocol for a randomised controlled trial

BACKGROUND: Patients often experience postoperative nausea and vomiting (PONV) after catheter ablation of atrial fibrillation (AF) because of the use of opioids for anaesthesia and analgesia during the procedure. Some clinical trials have demonstrated that acupuncture-assisted anaesthesia (AAA) redu...

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Autores principales: Zhang, Xuecheng, Wang, Qi, Dong, Yujiang, Jia, Yuqi, Hou, Zhihui, Deng, Wenqi, Zhang, Menghe, Mu, Qiurun, Jia, Hongling
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9756186/
https://www.ncbi.nlm.nih.gov/pubmed/36521882
http://dx.doi.org/10.1136/bmjopen-2022-068318
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author Zhang, Xuecheng
Wang, Qi
Dong, Yujiang
Jia, Yuqi
Hou, Zhihui
Deng, Wenqi
Zhang, Menghe
Mu, Qiurun
Jia, Hongling
author_facet Zhang, Xuecheng
Wang, Qi
Dong, Yujiang
Jia, Yuqi
Hou, Zhihui
Deng, Wenqi
Zhang, Menghe
Mu, Qiurun
Jia, Hongling
author_sort Zhang, Xuecheng
collection PubMed
description BACKGROUND: Patients often experience postoperative nausea and vomiting (PONV) after catheter ablation of atrial fibrillation (AF) because of the use of opioids for anaesthesia and analgesia during the procedure. Some clinical trials have demonstrated that acupuncture-assisted anaesthesia (AAA) reduces opioid consumption and prevents PONV. Although several studies have been conducted on AAA, its safety and efficacy in AF catheter ablation remain unclear due to small sample sizes and a paucity of methodologically rigorous designs. Therefore, this trial was designed to evaluate the safety and efficacy of AAA in reducing PONV and morphine hydrochloride consumption during catheter ablation. METHODS: This single-centre, patient-blinded, randomised, non-penetrating sham-controlled trial will be conducted in China. A total of 100 patients will be randomly assigned to the AAA and conventional anaesthesia (CA) groups in a ratio of 1:1. The patients will receive AAA or CA plus sham acupuncture during catheter ablation and will be followed up for 30 days. The primary outcomes include the total amount of morphine hydrochloride consumed during catheter ablation and PONV within the first 24 hours after the procedure. The secondary outcomes include pain, nausea and vomiting, anxiety, patient’s ability to cope during catheter ablation, AF recurrence and quality of life, as assessed using the numeric rating scale. Adverse events will be recorded and their influence will be analysed at the end of the trial. DISCUSSION: This study will help in evaluating the safety and efficacy of AAA applied for AF catheter ablation in reducing opioid doses during the procedure and the occurrence of PONV. ETHICS AND DISSEMINATION: The study has been approved by the Medical Ethics Committee of Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine. The results of the study will be published in peer-reviewed journals and presented at conferences if possible. TRIAL REGISTRATION NUMBER: ChiCTR 2100042646; Chinese Clinical Trial Registry.
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spelling pubmed-97561862022-12-17 Acupuncture-assisted anaesthesia for catheter ablation of atrial fibrillation to reduce the consumption of morphine hydrochloride and postoperative nausea and vomiting (PONV): study protocol for a randomised controlled trial Zhang, Xuecheng Wang, Qi Dong, Yujiang Jia, Yuqi Hou, Zhihui Deng, Wenqi Zhang, Menghe Mu, Qiurun Jia, Hongling BMJ Open Complementary Medicine BACKGROUND: Patients often experience postoperative nausea and vomiting (PONV) after catheter ablation of atrial fibrillation (AF) because of the use of opioids for anaesthesia and analgesia during the procedure. Some clinical trials have demonstrated that acupuncture-assisted anaesthesia (AAA) reduces opioid consumption and prevents PONV. Although several studies have been conducted on AAA, its safety and efficacy in AF catheter ablation remain unclear due to small sample sizes and a paucity of methodologically rigorous designs. Therefore, this trial was designed to evaluate the safety and efficacy of AAA in reducing PONV and morphine hydrochloride consumption during catheter ablation. METHODS: This single-centre, patient-blinded, randomised, non-penetrating sham-controlled trial will be conducted in China. A total of 100 patients will be randomly assigned to the AAA and conventional anaesthesia (CA) groups in a ratio of 1:1. The patients will receive AAA or CA plus sham acupuncture during catheter ablation and will be followed up for 30 days. The primary outcomes include the total amount of morphine hydrochloride consumed during catheter ablation and PONV within the first 24 hours after the procedure. The secondary outcomes include pain, nausea and vomiting, anxiety, patient’s ability to cope during catheter ablation, AF recurrence and quality of life, as assessed using the numeric rating scale. Adverse events will be recorded and their influence will be analysed at the end of the trial. DISCUSSION: This study will help in evaluating the safety and efficacy of AAA applied for AF catheter ablation in reducing opioid doses during the procedure and the occurrence of PONV. ETHICS AND DISSEMINATION: The study has been approved by the Medical Ethics Committee of Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine. The results of the study will be published in peer-reviewed journals and presented at conferences if possible. TRIAL REGISTRATION NUMBER: ChiCTR 2100042646; Chinese Clinical Trial Registry. BMJ Publishing Group 2022-12-14 /pmc/articles/PMC9756186/ /pubmed/36521882 http://dx.doi.org/10.1136/bmjopen-2022-068318 Text en © Author(s) (or their employer(s)) 2022. 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 Complementary Medicine
Zhang, Xuecheng
Wang, Qi
Dong, Yujiang
Jia, Yuqi
Hou, Zhihui
Deng, Wenqi
Zhang, Menghe
Mu, Qiurun
Jia, Hongling
Acupuncture-assisted anaesthesia for catheter ablation of atrial fibrillation to reduce the consumption of morphine hydrochloride and postoperative nausea and vomiting (PONV): study protocol for a randomised controlled trial
title Acupuncture-assisted anaesthesia for catheter ablation of atrial fibrillation to reduce the consumption of morphine hydrochloride and postoperative nausea and vomiting (PONV): study protocol for a randomised controlled trial
title_full Acupuncture-assisted anaesthesia for catheter ablation of atrial fibrillation to reduce the consumption of morphine hydrochloride and postoperative nausea and vomiting (PONV): study protocol for a randomised controlled trial
title_fullStr Acupuncture-assisted anaesthesia for catheter ablation of atrial fibrillation to reduce the consumption of morphine hydrochloride and postoperative nausea and vomiting (PONV): study protocol for a randomised controlled trial
title_full_unstemmed Acupuncture-assisted anaesthesia for catheter ablation of atrial fibrillation to reduce the consumption of morphine hydrochloride and postoperative nausea and vomiting (PONV): study protocol for a randomised controlled trial
title_short Acupuncture-assisted anaesthesia for catheter ablation of atrial fibrillation to reduce the consumption of morphine hydrochloride and postoperative nausea and vomiting (PONV): study protocol for a randomised controlled trial
title_sort acupuncture-assisted anaesthesia for catheter ablation of atrial fibrillation to reduce the consumption of morphine hydrochloride and postoperative nausea and vomiting (ponv): study protocol for a randomised controlled trial
topic Complementary Medicine
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9756186/
https://www.ncbi.nlm.nih.gov/pubmed/36521882
http://dx.doi.org/10.1136/bmjopen-2022-068318
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