NCT07194109尚未招募4 期
Remiazolam vs Propofol Total Intravenous Anesthesia on Postoperative Neurodevelopment After General Anesthesia in Children
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 558
- 主要终点
- full-scale intelligence quotient
研究概览
简要总结
The goal of this clinical trial is to learn the effects of remimazolam for total intravenous anesthesia on the neurodevelopment of children aged 3-6 years who underwent tonsil/adenoid removal surgery after general anesthesia when compared with propofol. It will also learn about the safety of remimazolam used for children. The main questions it aims to answer are:
- Does remimazolam improve the postoperative neurodevelopmental outcomes of the children after general anesthesia compared with propofol?
- What medical problems do participants have when receive remimazolam for general anesthesia? Researchers will compare remimazolam to propofol to see if remimazolam improve the postoperative neurodevelopmental outcomes of the children after general anesthesia.
Participants will:
- Receive remimazolam or propofol for general anesthesia induction and maintenance
- At 1-3 years after the surgery, the Wechsler Preschool and Primary Scale of Intelligence - Fourth Edition was used for face-to-face assessment of the children's neurodevelopmental status.
- Use scales such as BRIEF-P and CBCL to conduct face-to-face assessments of the patient's cognitive functions in other areas.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 3-6 years old;
- •Planned to undergo elective non-neurological, non-cardiac, and non-liver surgery under general anesthesia (abdominal surgery, orthopedic surgery, urological surgery, otolaryngological surgery, etc.);
- •Expected anesthesia duration to be more than 30 minutes;
- •ASA classification I-II;
- •BMI 14-25 kg/m2;
- •Postoperative plan not to be admitted to ICU;
- •Parents or legal guardians of the child have given informed consent;
- •Capable of communicating in Chinese.
排除标准
- •Those who were exposed to general anesthetic drugs during infancy or in the late pregnancy of the mother;
- •Known chromosomal abnormalities or other known acquired or congenital diseases that may affect neural development, such as cerebral palsy, autism spectrum disorder or attention deficit hyperactivity disorder (ADHD), etc.;
- •Patients with severe liver dysfunction (Child-Pugh C grade);
- •Patients with severe kidney dysfunction (requiring dialysis before surgery);
- •Patients with a history of congenital heart disease requiring surgery or drug treatment;
- •Those allergic to the study drugs remimazolam or propofol;
- •Any known neural damage, such as cystic periventricular leukomalacia or grade 3 or 4 intraventricular hemorrhage;
- •Social or geographical factors that may lead to postoperative loss of follow-up;
- •Planned to undergo two surgeries within 7 days after the surgery;
- •Those currently participating in other clinical trials;
- •Those receiving special care or living in social welfare institutions or any other factors that may affect their ability to participate in the study.
研究组 & 干预措施
Remimazolam group
Experimental
patients who in this arm will receive remimazolam for general anesthesia induction and maintenance
干预措施: Remimazolam based total intravenous anesthesia (Drug)
propofol group
Active Comparator
patients who in this arm will receive propofol for general anesthesia induction and maintenance
干预措施: Propofol based general anesthesia (Drug)
结局指标
主要结局
full-scale intelligence quotient
时间窗: one year after surgery
assessed by trained physicians, using the Wechsler Preschool and Primary Scale of Intelligence - Fourth Edition (Chinese Version) 《WPPSI-IV(CN)》
次要结局
- Memory and learning ability(The first to the third year after the operation)
- Language and Reading Skills(The first to the third year after the operation)
- Executive Function and Attention(The first to third year after operation)
- Behavior and Emotion Assessment(The first to third year after surgery)
- Motor development(The first to third years after surgery)
研究者
相似试验
招募中
4 期
REmimazolam vs Propofol Total Intravenous Anesthesia on Outcomes After Major Noncardiac SurgEryAnesthesiaSurgery-ComplicationsNCT05728775Nanfang Hospital, Southern Medical University7,188
尚未招募
4 期
Comparison of Remimazolam and Propofol Combination vs. Propofol in IOMNeurologic DisorderNCT06382467Chung-Ang University Gwangmyeong Hospital56
已完成
2 期
Remimazolam Versus Propofol for Painless AbortionAnesthesiaAbortion EarlyNCT05635955Maternal and Child Health Hospital of Hubei Province100
已完成
2 期
A Study Comparing Remimazolam Tosilate and Propofol for Intravenous General Anaesthesia in OperationsGeneral AnesthesiaNCT02406872Jiangsu HengRui Medicine Co., Ltd.144
尚未招募
不适用
The Effect of General Anesthesia with Remimazolam and Propofol on Rhythmic State and Cognitive FunctionNCT06775366The Second Affiliated Hospital of Chongqing Medical University174