Department of Anesthesiology, Fuwai Hospital, National Center for Cardiovascular Diseases, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, China.
Department of Anesthesiology, Jingmen No. 1 People's Hospital, Jingmen, China.
BMJ Open. 2020 Jun 17;10(6):e035691. doi: 10.1136/bmjopen-2019-035691.
Cough is often observed when administrating a bolus of opioids. Opioid-induced cough (OIC) is mostly transient, benign and self-limiting, but could be associated with adverse effects. Numerous pharmacological and non-pharmacological interventions have been used to manage OIC with controversial efficacy and safety. Recent studies suggested that, pretreatment of intravenous dezocine (DZC) could completely suppress OIC during anaesthesia induction. To address this knowledge lack, we will perform a systemic review and meta-analysis to evaluate the efficacy of DZC on OIC and possible complications. We provide here a protocol that will outline the methods and analyses planned for the systematic review.
PubMed, Embase, Cochrane Library, Web of Science as well as Chinese BioMedical Literature & Retrieval System (SinoMed), China National Knowledge Infrastructure, Wanfang Data and VIP Data will be searched from 1978 to 31 December 2019 to identify all randomised controlled trials comparing DZC with placebo on the incidence and severity of OIC. Primary outcomes of interest include the incidence and severity of OIC. Secondary outcomes of interest include possible complications or adverse effects of DZC. Two authors will independently extract relevant variables and outcome data. For continuous variables, treatment effects will be calculated as weighted mean difference and 95% CI. For dichotomous data, treatment effects will be calculated as OR and 95% CI. Each outcome will be tested for heterogeneity, and randomised-effects or fixed-effects model will be used in the presence or absence of significant heterogeneity. Sensitivity analyses will be done by examining the influence of statistical model and individual trial(s) on estimated treatment effects. Publication bias will be explored through visual inspection of funnel plots of the outcomes. Statistical significance will be defined as p<0.05.
This study is a protocol of meta-analysis of previously published literatures, ethical approval was not necessary according to the Ethical Committee of Fuwai Hospital. The study will be submitted to a peer-reviewed journal and disseminated via research presentations.
CRD42019141255.
给予阿片类药物推注时经常会观察到咳嗽。阿片类药物引起的咳嗽(OIC)大多是短暂的、良性的、自限性的,但可能与不良反应有关。已经使用了许多药理学和非药理学干预措施来治疗 OIC,但疗效和安全性存在争议。最近的研究表明,静脉注射地佐辛(DZC)预处理可在麻醉诱导期间完全抑制 OIC。为了解决这一知识空白,我们将进行系统评价和荟萃分析,以评估 DZC 治疗 OIC 和可能的并发症的疗效。我们在此提供一个方案,概述了系统评价计划的方法和分析。
从 1978 年至 2019 年 12 月 31 日,我们将检索 PubMed、Embase、Cochrane 图书馆、Web of Science 以及中国生物医学文献数据库(SinoMed)、中国国家知识基础设施(CNKI)、万方数据(Wanfang Data)和维普数据(VIP Data),以确定所有比较 DZC 与安慰剂对 OIC 发生率和严重程度的随机对照试验。主要观察指标包括 OIC 的发生率和严重程度。次要观察指标包括 DZC 的可能并发症或不良反应。两名作者将独立提取相关变量和结局数据。对于连续变量,治疗效果将计算为加权均数差和 95%CI。对于二分类数据,治疗效果将计算为 OR 和 95%CI。对于每个结局,将进行异质性检验,并在存在或不存在显著异质性的情况下使用随机效应或固定效应模型。通过检查统计模型和单个试验对估计治疗效果的影响,进行敏感性分析。通过视觉检查结局的漏斗图来探索发表偏倚。将定义 p<0.05 为具有统计学意义。
本研究是对先前发表文献的荟萃分析方案,根据阜外医院伦理委员会的规定,不需要伦理批准。该研究将提交给同行评议的期刊,并通过研究报告进行传播。
PROSPERO 注册号:CRD42019141255。