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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
by
Sun, Fei
, Si, Zhenqiang
, Shen, Fangming
, Zhang, Li
, Hu, Zhen
, Sun, Jie
, Cai, Weiwei
, Liu, Lu
in
Ambulatory care
/ Ambulatory Surgical Procedures - adverse effects
/ Anaesthetic protocols
/ Anesthetics, Inhalation - administration & dosage
/ Anesthetics, Inhalation - adverse effects
/ Anesthetics, Intravenous - administration & dosage
/ Anesthetics, Intravenous - adverse effects
/ Behavior
/ Biomedicine
/ Brain research
/ Child
/ Child Behavior - drug effects
/ Child, Preschool
/ Children
/ Children & youth
/ China
/ Clinical trials
/ Day surgery
/ Delirium
/ Drugs
/ Electroencephalographic forms
/ Electroencephalography
/ Electroencephalography - drug effects
/ Emergence Delirium
/ Female
/ General anesthesia
/ Health Sciences
/ Hospital costs
/ Humans
/ Infant
/ Intraoperative Neurophysiological Monitoring
/ Male
/ Medical colleges
/ Medical research
/ Medicine
/ Medicine & Public Health
/ Medicine, Experimental
/ Multicenter Studies as Topic
/ Negative postoperative behavioural changes
/ Paediatric patients
/ Pediatric anesthesia
/ Pediatrics
/ Propofol - administration & dosage
/ Propofol - adverse effects
/ Prospective Studies
/ Randomized Controlled Trials as Topic
/ Remifentanil
/ Sevoflurane - administration & dosage
/ Sevoflurane - adverse effects
/ Single-Blind Method
/ Statistics for Life Sciences
/ Study Protocol
/ Sufentanil
/ Surgery
/ Surgical clinics
/ Time Factors
2025
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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
by
Sun, Fei
, Si, Zhenqiang
, Shen, Fangming
, Zhang, Li
, Hu, Zhen
, Sun, Jie
, Cai, Weiwei
, Liu, Lu
in
Ambulatory care
/ Ambulatory Surgical Procedures - adverse effects
/ Anaesthetic protocols
/ Anesthetics, Inhalation - administration & dosage
/ Anesthetics, Inhalation - adverse effects
/ Anesthetics, Intravenous - administration & dosage
/ Anesthetics, Intravenous - adverse effects
/ Behavior
/ Biomedicine
/ Brain research
/ Child
/ Child Behavior - drug effects
/ Child, Preschool
/ Children
/ Children & youth
/ China
/ Clinical trials
/ Day surgery
/ Delirium
/ Drugs
/ Electroencephalographic forms
/ Electroencephalography
/ Electroencephalography - drug effects
/ Emergence Delirium
/ Female
/ General anesthesia
/ Health Sciences
/ Hospital costs
/ Humans
/ Infant
/ Intraoperative Neurophysiological Monitoring
/ Male
/ Medical colleges
/ Medical research
/ Medicine
/ Medicine & Public Health
/ Medicine, Experimental
/ Multicenter Studies as Topic
/ Negative postoperative behavioural changes
/ Paediatric patients
/ Pediatric anesthesia
/ Pediatrics
/ Propofol - administration & dosage
/ Propofol - adverse effects
/ Prospective Studies
/ Randomized Controlled Trials as Topic
/ Remifentanil
/ Sevoflurane - administration & dosage
/ Sevoflurane - adverse effects
/ Single-Blind Method
/ Statistics for Life Sciences
/ Study Protocol
/ Sufentanil
/ Surgery
/ Surgical clinics
/ Time Factors
2025
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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
by
Sun, Fei
, Si, Zhenqiang
, Shen, Fangming
, Zhang, Li
, Hu, Zhen
, Sun, Jie
, Cai, Weiwei
, Liu, Lu
in
Ambulatory care
/ Ambulatory Surgical Procedures - adverse effects
/ Anaesthetic protocols
/ Anesthetics, Inhalation - administration & dosage
/ Anesthetics, Inhalation - adverse effects
/ Anesthetics, Intravenous - administration & dosage
/ Anesthetics, Intravenous - adverse effects
/ Behavior
/ Biomedicine
/ Brain research
/ Child
/ Child Behavior - drug effects
/ Child, Preschool
/ Children
/ Children & youth
/ China
/ Clinical trials
/ Day surgery
/ Delirium
/ Drugs
/ Electroencephalographic forms
/ Electroencephalography
/ Electroencephalography - drug effects
/ Emergence Delirium
/ Female
/ General anesthesia
/ Health Sciences
/ Hospital costs
/ Humans
/ Infant
/ Intraoperative Neurophysiological Monitoring
/ Male
/ Medical colleges
/ Medical research
/ Medicine
/ Medicine & Public Health
/ Medicine, Experimental
/ Multicenter Studies as Topic
/ Negative postoperative behavioural changes
/ Paediatric patients
/ Pediatric anesthesia
/ Pediatrics
/ Propofol - administration & dosage
/ Propofol - adverse effects
/ Prospective Studies
/ Randomized Controlled Trials as Topic
/ Remifentanil
/ Sevoflurane - administration & dosage
/ Sevoflurane - adverse effects
/ Single-Blind Method
/ Statistics for Life Sciences
/ Study Protocol
/ Sufentanil
/ Surgery
/ Surgical clinics
/ Time Factors
2025
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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
Journal Article
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
2025
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Overview
Background
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.
Methods
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.
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 registration
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.
Publisher
BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
Subject
/ Ambulatory Surgical Procedures - adverse effects
/ Anesthetics, Inhalation - administration & dosage
/ Anesthetics, Inhalation - adverse effects
/ Anesthetics, Intravenous - administration & dosage
/ Anesthetics, Intravenous - adverse effects
/ Behavior
/ Child
/ Child Behavior - drug effects
/ Children
/ China
/ Delirium
/ Drugs
/ Electroencephalographic forms
/ Electroencephalography - drug effects
/ Female
/ Humans
/ Infant
/ Intraoperative Neurophysiological Monitoring
/ Male
/ Medicine
/ Multicenter Studies as Topic
/ Negative postoperative behavioural changes
/ Propofol - administration & dosage
/ Randomized Controlled Trials as Topic
/ Sevoflurane - administration & dosage
/ Sevoflurane - adverse effects
/ Statistics for Life Sciences
/ Surgery
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