医学
随机对照试验
协议(科学)
类阿片
麻醉
临床试验
外科
替代医学
内科学
受体
病理
作者
Yuxuan Fu,Yang Zhou,Yidan Cui,Youxuan Wu,Tianyuan Wang,Yang Li,Yun Yu,Ruquan Han
出处
期刊:BMJ Open
[BMJ]
日期:2025-05-01
卷期号:15 (5): e099864-e099864
标识
DOI:10.1136/bmjopen-2025-099864
摘要
Introduction Opioids play a pivotal role in being capable of effectively blocking the pain and stress responses triggered by procedures such as surgery and intubation. However, it should not be overlooked that opioids have numerous side effects, such as respiratory depression, postoperative nausea and vomiting. These effects can raise intracranial pressure, posing a life-threatening risk in neurosurgical patients. Opioid-free anaesthesia can prevent or significantly reduce opioid usage. The aim of this study is to investigate the effect of opioid-free anaesthesia on the quality of recovery in patients undergoing supratentorial tumour resection in neurosurgery. Methods and analysis This is a single-centre, randomised controlled clinical trial. A total of 170 patients receiving general anaesthesia will be randomised in a 1:1 ratio into two groups, one receiving opioid-free anaesthesia and the other receiving opioid-based anaesthesia. The primary outcome measure is the Quality of Recovery-15 Score on the second day after surgery. The secondary outcomes include the Quality of Recovery Score on the fifth day, the incidence of nausea and vomiting within 48 hours, the NRS Pain Score on the second and fifth days, the sleep quality on the second and fifth days after surgery, and the incidence of chronic pain at 3 months and 6 months after surgery. Ethics and dissemination This study received official approval from the Ethics Committee of Beijing Tiantan Hospital, Capital Medical University, on 9 September 2024 (KY2024-219-02). The findings of this study are intended to be disseminated through publications in international peer-reviewed journals, presentations at national and international academic conferences, and broad distribution via online platforms. Trial registration number ClincalTrials.gov, NCT06607029 (15 September 2024)
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