METHODS: This study is a single-centre, randomised, parallel-controlled trial being conducted in Beijing, China. A total of 50 paediatric patients with cerebral palsy scheduled for SPR are randomised in a 1:1 ratio to receive bilateral TLIP block with 0.2% ropivacaine 0.5 mL/kg or control. Patients in the TLIP group receive general anaesthesia combined with TLIP block, while patients in the control group receive only general anaesthesia, without a TLIP block. The primary outcome is the Paediatric Anaesthesia Emergence Delirium Score. The secondary outcomes are the incidence of EA, the Wong-Baker Faces Pain-rating Scale, the perioperative haemodynamics, the intraoperative remifentanil and propofol dosage, the extubation time and recovery time, and adverse reactions.
BACKGROUND: This study was approved by the Ethics Committee of Dongzhimen Hospital, Beijing University of Chinese Medicine on 21 September 2023 (2023DZMEC-379-02). Written informed consent is obtained from the legal guardian of each patient. The results of this study will be published in peer-reviewed international journals.
BACKGROUND: ChiCTR2300076397.
方法:本研究是单中心,随机化,在北京进行的平行对照试验,中国。总共50名计划进行SPR的小儿脑瘫患者以1:1的比例随机分配,接受0.2%罗哌卡因0.5mL/kg的双侧TLIP阻滞或对照。TLIP组患者接受全麻联合TLIP阻滞,而对照组患者仅接受全身麻醉,没有TLIP块。主要结果是小儿麻醉出现谵妄评分。次要结果是EA的发生率,Wong-Baker面临疼痛评定量表,围手术期血流动力学,术中瑞芬太尼和丙泊酚的用量,拔管时间和恢复时间,和不良反应。
背景:本研究经东直门医院伦理委员会批准,北京中医药大学,2023年9月21日(2023DZMEC-379-02)。书面知情同意书从每个患者的法定监护人获得。这项研究的结果将发表在同行评审的国际期刊上。
背景:ChiCTR2300076397。