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幕上肿瘤切除术患者的无阿片类麻醉与术后恢复质量:一项随机对照试验方案

Opioid-free anaesthesia and postoperative quality of recovery in patients undergoing supratentorial tumour resection: protocol for a randomised controlled trial.

作者信息

Fu Yuxuan, Zhou Yang, Cui Yidan, Wu Youxuan, Wang Tianyuan, Li Yang, Yu Yun, Han Ruquan

机构信息

Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.

Beijing Nuclear Industry Hospital, Beijing, China.

出版信息

BMJ Open. 2025 May 15;15(5):e099864. doi: 10.1136/bmjopen-2025-099864.

Abstract

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).

摘要

引言

阿片类药物在有效阻断手术和插管等操作引发的疼痛和应激反应方面发挥着关键作用。然而,不应忽视的是,阿片类药物有许多副作用,如呼吸抑制、术后恶心和呕吐。这些影响可升高颅内压,给神经外科患者带来危及生命的风险。无阿片类药物麻醉可预防或显著减少阿片类药物的使用。本研究的目的是探讨无阿片类药物麻醉对神经外科幕上肿瘤切除患者恢复质量的影响。

方法与分析

这是一项单中心随机对照临床试验。总共170例接受全身麻醉的患者将按1:1比例随机分为两组,一组接受无阿片类药物麻醉,另一组接受基于阿片类药物的麻醉。主要结局指标是术后第二天的恢复质量-15评分。次要结局包括术后第五天的恢复质量评分、48小时内恶心和呕吐的发生率、术后第二天和第五天的数字评定量表疼痛评分、术后第二天和第五天的睡眠质量,以及术后3个月和6个月慢性疼痛的发生率。

伦理与传播

本研究于2024年9月9日获得首都医科大学附属北京天坛医院伦理委员会的正式批准(KY2024-219-02)。本研究的结果拟通过在国际同行评审期刊上发表、在国内和国际学术会议上报告以及通过在线平台广泛传播。

试验注册号

ClincalTrials.gov,NCT06607029(2024年9月15日)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/23b1/12083393/5770fa8e76f2/bmjopen-15-5-g001.jpg

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