Sun Fei, Shen Fangming, Cai Weiwei, Si Zhenqiang, Hu Zhen, Liu Lu, Sun Jie, Zhang Li
Department of Anaesthesiology, Children's Hospital of Nanjing Medical University, No. 72 Guangzhou Road, Nanjing City , Jiangsu Province, 210008, China.
Department of Anesthesiology & Key Laboratory of Clinical Science and Research, Zhongda Hospital, Southeast University, No. 87Dingjiaqiao, Nanjing City , Jiangsu Province, 210009, China.
Trials. 2025 Jul 20;26(1):252. doi: 10.1186/s13063-025-08962-z.
Negative postoperative behavioural changes (NPOBCs) are among the most common complications of paediatric anaesthesia. The association between electroencephalogram (EEG) suppression and postoperative outcomes in previous clinical studies has been limited to delirium occurring early in the anaesthesia recovery room, and there are no reports of associations with negative postoperative behavioural changes in the distant postoperative period. However, this has important implications for children undergoing day surgery who are discharged on the same day after surgery.
The objective of this study is to investigate the mediating effects of intraoperative EEG patterns and negative postoperative behavioural changes in children undergoing paediatric day surgery. This study is a two-centre, prospective, randomised, single-blind, controlled trial involving 854 paediatric patients undergoing day surgery at the Children's Hospital of Nanjing Medical University and Zhongda Hospital of Southeast University; these patients are randomly assigned into two groups: the propofol intravenous anaesthesia, which is induced and maintained with propofol, group (Group T) and the sevoflurane inhalation anaesthesia, which is induced and maintained with sevoflurane, group (Group S). The depth of anaesthesia is monitored for both groups of children, and the EEG characteristics of the children are extracted. The primary outcome measure is the incidence of negative behavioural changes during the first three days after surgery. The secondary outcomes include evaluating the incidence of negative behavioural changes at 1, 7, and 28 days postoperatively and investigating the relationship between intraoperative EEG patterns and NPOBCs. The study flow diagram is presented in Fig. 1.
The aim of this clinical trial is to prospectively observe the mediating effects of intraoperative EEG forms and negative postoperative behavioural changes in children undergoing paediatric day surgery and to further explore the possible mechanisms of negative postoperative behavioural changes in paediatric anaesthesia. Moreover, in paediatric day surgery, the postoperative discharge assessment of children still lacks the ability to predict negative postoperative behavioural changes, and this study will construct a prediction model of negative postoperative behavioural changes to help anaesthesiologists more comprehensively assess whether children meet the criteria for discharge and to improve the quality of postoperative rehabilitation of children.
The study protocol was registered with the China Clinical Trial Registry ( http://www.chictr.org.cn ) on 1 July 2024 under the registration number ChiCTR2400086403. This trial is retrospectively registered.
术后负面行为改变（NPOBCs）是小儿麻醉最常见的并发症之一。先前临床研究中脑电图（EEG）抑制与术后结局之间的关联仅限于麻醉恢复室早期出现的谵妄，尚无关于与术后远期负面行为改变存在关联的报道。然而，这对于术后当天出院的日间手术患儿具有重要意义。
本研究的目的是调查小儿日间手术患儿术中脑电图模式与术后负面行为改变的中介作用。本研究是一项两中心、前瞻性、随机、单盲、对照试验，涉及南京医科大学附属儿童医院和东南大学附属中大医院的854例接受日间手术的儿科患者；这些患者被随机分为两组：丙泊酚静脉麻醉组（T组），采用丙泊酚诱导和维持麻醉；七氟醚吸入麻醉组（S组），采用七氟醚诱导和维持麻醉。对两组患儿的麻醉深度进行监测，并提取患儿的脑电图特征。主要结局指标是术后前三天负面行为改变的发生率。次要结局包括评估术后1天、7天和28天负面行为改变的发生率，并研究术中脑电图模式与NPOBCs之间的关系。研究流程图见图1。
本临床试验的目的是前瞻性观察小儿日间手术患儿术中脑电图形式与术后负面行为改变的中介作用，并进一步探索小儿麻醉术后负面行为改变的可能机制。此外，在小儿日间手术中，对患儿术后出院的评估仍缺乏预测术后负面行为改变的能力，本研究将构建术后负面行为改变的预测模型，以帮助麻醉医生更全面地评估患儿是否符合出院标准，提高患儿术后康复质量。
该研究方案于2024年7月1日在中国临床试验注册中心（http://www.chictr.org.cn）注册，注册号为ChiCTR2400086403。本试验为回顾性注册。
