PDF(Pubmed)
Abstract：
Background: Remimazolam, a new ultrashort-acting benzodiazepine, is becoming increasingly applied in general anesthesia. This study is designed to investigate the effect of remimazolam-based total intravenous anesthesia and sevoflurane-based inhalation anesthesia on emergence delirium in pediatric tonsillectomy and adenoidectomy. Methods and analysis: This is a monocentric, prospective, randomized, double-blind clinical trial. A total of 90 pediatric patients will be randomized to receive remimazolam-based total intravenous anesthesia (remimazolam group, n = 45) or sevoflurane-based inhalation anesthesia (sevoflurane group, n = 45). The primary outcome will be the incidence of emergence delirium, which will be evaluated using the Pediatric Anesthesia Emergence Delirium (PAED) scale. The secondary outcomes include the extubation time, recovery time, behavior change using the post-hospitalization behavior questionnaire for ambulatory surgery (PHBQ-AS), and adverse events. Ethics and dissemination: This study has been approved by the Institutional Review Board (IRB) of the Second Affiliated Hospital and Yuying Children\'s Hospital of Wenzhou Medical University (2023-K-262-02). Clinical trial registration: ClinicalTrials.gov, identifier NCT06214117.
摘要：
背景：雷米唑仑，一种新的超短作用苯二氮卓类药物，越来越多地应用于全身麻醉。本研究旨在探讨以瑞马唑仑为基础的全静脉麻醉和以七氟醚为基础的吸入麻醉对小儿扁桃体和腺样体切除术中出现谵妄的影响。方法和分析：这是一个单中心，prospective,随机化，双盲临床试验。共有90名儿科患者将被随机分配接受以瑞咪唑安定为基础的全静脉麻醉(瑞咪唑安定组,n=45）或七氟醚吸入麻醉（七氟醚组，n=45）。主要结果将是出现谵妄的发生率，将使用小儿麻醉出现谵妄（PAED）量表进行评估。次要结果包括拔管时间，恢复时间,使用门诊手术住院后行为问卷（PHBQ-AS）的行为变化，和不良事件。伦理与传播：本研究已获得温州医科大学附属第二医院和育英儿童医院机构审查委员会（IRB）的批准（2023-K-262-02）。临床试验注册：ClinicalTrials.gov，标识符NCT06214117。
