Department of Anesthesiology, Shanghai East Hospital, Shanghai, China.
The First Clinical Medical College, Gansu University of Traditional Chinese Medicine, Lanzhou, China.
BMJ Open. 2023 May 31;13(5):e071438. doi: 10.1136/bmjopen-2022-071438.
Painless gastrointestinal endoscopy is being increasingly practised in the clinical field. The management and choice of sedation are important during the endoscopy procedure to reduce patient discomfort and facilitate high disease detection rates. Ciprofol is principally an agonist of the γ-aminobutyric acid type A receptor; it comprises the active ingredient HSK3486, which is similar to the currently used intravenous anaesthetic propofol in clinical practice. A systematic review and meta-analysis comparing ciprofol and propofol will be conducted to assess their efficacy and safety during endoscopy. Before starting the study, we describe the specific protocol of this systematic review.
This protocol was prepared in accordance with the Preferred Reporting Items for Systematic Review and Meta-analysis Protocols 2015. The following databases will be searched: Embase, Cochrane Library, PubMed, Web of Science, Chinese Biomedical Literature Service System, China National Knowledge Infrastructure, Wanfang Database, China Science and Technology Journal Database and a clinical trial registry. The database search strategy will adopt a combination of subject words and free words. Randomised controlled trials related to ciprofol use for sedation during gastrointestinal endoscopy will also be included. Based on the inclusion and exclusion criteria, two researchers will independently screen the articles and extracted data. Following the qualitative evaluation of each study, analysis will be conducted using Review Manager software.
The protocol for this systematic review and meta-analysis involves no individual patient data; thus, ethical approval is not required. This will be the first meta-analysis to assess the sedation efficacy of ciprofol and provide evidence to clinicians for decision-making. The results will be disseminated through conference presentations and publications in peer-review journals related to this field.
CRD42022370047.
无痛胃肠内镜在临床领域的应用越来越广泛。在内镜检查过程中，管理和选择镇静剂对于减轻患者不适和提高疾病检出率非常重要。Ciprofol 主要是γ-氨基丁酸 A 型受体激动剂；它包含 HSK3486 作为活性成分，与目前临床实践中使用的静脉麻醉药丙泊酚相似。我们将进行一项系统评价和荟萃分析，比较 Ciprofol 和丙泊酚在内镜检查中的疗效和安全性。在开始研究之前，我们将描述本系统评价的具体方案。
本方案按照 2015 年《系统评价和荟萃分析首选报告项目》的要求制定。将检索以下数据库：Embase、Cochrane 图书馆、PubMed、Web of Science、中国生物医学文献服务系统、中国国家知识基础设施、万方数据库、中国科技期刊数据库和临床试验注册库。数据库搜索策略将采用主题词和自由词相结合的方式。还将纳入有关 Ciprofol 用于胃肠内镜镇静的随机对照试验。根据纳入和排除标准，两名研究人员将独立筛选文章并提取数据。在对每个研究进行定性评估后，将使用 Review Manager 软件进行分析。
本系统评价和荟萃分析方案不涉及个体患者数据，因此不需要伦理批准。这将是第一项评估 Ciprofol 镇静效果的荟萃分析，并为临床医生提供决策依据。结果将通过会议演示和发表在与该领域相关的同行评议期刊上进行传播。
PROSPERO 注册号：CRD42022370047。
