Evidence map›Paper›PMID 40685366›Full record

ArticleTrials2025

Exploring the associations between intraoperative electroencephalographic depression mediated by different anaesthetic drugs and negative postoperative behavioural changes in children undergoing day surgery: a protocol for a two-centre randomised clinical trial.

Fei Sun, Fangming Shen, Weiwei Cai, Zhenqiang Si, Zhen Hu, Lu Liu, Jie Sun, Li Zhang

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper, 1 of them a synthesis that pooled it.

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0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
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1 · What the graph read from it

What it found

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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

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Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it.

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4 · The record

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5 · Who and what money

Authors and funding

8 authors.

Fei Sun *Department of Anaesthesiology, Children's Hospital of Nanjing Medical University, No. 72 Guangzhou Road, Nanjing City , Jiangsu Province, 210008, China.
Fangming Shen *Department of Anesthesiology & Key Laboratory of Clinical Science and Research, Zhongda Hospital, Southeast University, No. 87Dingjiaqiao, Nanjing City , Jiangsu Province, 210009, China.
Weiwei CaiDepartment of Anaesthesiology, Children's Hospital of Nanjing Medical University, No. 72 Guangzhou Road, Nanjing City , Jiangsu Province, 210008, China.
Zhenqiang SiDepartment of Anaesthesiology, Children's Hospital of Nanjing Medical University, No. 72 Guangzhou Road, Nanjing City , Jiangsu Province, 210008, China.
Zhen HuDepartment of Anaesthesiology, Children's Hospital of Nanjing Medical University, No. 72 Guangzhou Road, Nanjing City , Jiangsu Province, 210008, China.
Lu LiuDepartment of Anaesthesiology, Children's Hospital of Nanjing Medical University, No. 72 Guangzhou Road, Nanjing City , Jiangsu Province, 210008, China.
Jie SunDepartment of Anesthesiology & Key Laboratory of Clinical Science and Research, Zhongda Hospital, Southeast University, No. 87Dingjiaqiao, Nanjing City , Jiangsu Province, 210009, China.
Li ZhangDepartment of Anaesthesiology, Children's Hospital of Nanjing Medical University, No. 72 Guangzhou Road, Nanjing City , Jiangsu Province, 210008, China. drzhangli@njmu.edu.cn.ORCID http://orcid.org/0009-0009-5145-8613

Funding

The Second Batch of Clinical Research Projects of Nanjing Medical University Affiliated Children's Hospital LCYJY202320
6 · The paper itself

Abstract

backgroundNegative 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.

methodsThe 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. DISCUSSION: 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.

trial registrationThe 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.

Indexed as

Ambulatory Surgical ProceduresAnesthetics, IntravenousChild BehaviorElectroencephalographyPropofolSevofluraneAnesthetics, InhalationChildChild, PreschoolChinaEmergence DeliriumFemaleHumansInfantIntraoperative Neurophysiological MonitoringMaleAnesthetics, InhalationAnesthetics, IntravenousPropofolSevofluraneAnaesthetic protocolsDay surgeryElectroencephalographic formsNegative postoperative behavioural changesPaediatric patients

Identifiers

PMID40685366
PMCPMC12278671

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.