Abstract | BACKGROUND: 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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Authors | Xuecheng Zhang, Qi Wang, Yujiang Dong, Yuqi Jia, Zhihui Hou, Wenqi Deng, Menghe Zhang, Qiurun Mu, Hongling Jia |
Journal | BMJ open
(BMJ Open)
Vol. 12
Issue 12
Pg. e068318
(12 15 2022)
ISSN: 2044-6055 [Electronic] England |
PMID | 36521882
(Publication Type: Clinical Trial Protocol, Journal Article, Research Support, Non-U.S. Gov't)
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Copyright | © 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. |
Chemical References |
- Analgesics, Opioid
- Morphine
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Topics |
- Humans
- Acupuncture Therapy
(methods)
- Analgesics, Opioid
(therapeutic use)
- Anesthesia
- Atrial Fibrillation
(surgery)
- Catheter Ablation
- Morphine
(therapeutic use)
- Postoperative Nausea and Vomiting
(prevention & control)
- Quality of Life
- Randomized Controlled Trials as Topic
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