About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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);
Trial design
Parallel
Treatments tested in this trial
Remimazolam based total intravenous anesthesia
DrugFor patients who aged between 3 and 6 years old undergoing tonsillectomy or/and adenoidectomy, anesthesia induction will performed with remimazolam in a dose of 0.4 - 0.5 mg/kg anesthesia maintenance was administered with remimazolam at a rate of 1.0 - 3.0 mg/kg/h.
Propofol based general anesthesia
DrugFor patients who aged between 3 and 6 years old undergoing tonsillectomy or/and adenoidectomy, anesthesia induction will performed with propofol in a dose of 2.0 - 3.5 mg/kg , anesthesia maintenance was administered with propofol at a rate of 4 - 12 mg/kg/h.
Treatment groups
Trial outcomes
Primary outcomes
full-scale intelligence quotient
assessed by trained physicians, using the Wechsler Preschool and Primary Scale of Intelligence - Fourth Edition (Chinese Version) 《WPPSI-IV(CN)》
Secondary outcomes
Memory and learning ability
assessed by trained physicians, using the Wechsler Preschool and Primary Scale of Intelligence - Fourth Edition (Chinese Version) 《WPPSI-IV(CN)》
Language and Reading Skills
assessed by trained physicians, using the Wechsler Preschool and Primary Scale of Intelligence - Fourth Edition (Chinese Version) 《WPPSI-IV(CN)》
Executive Function and Attention
used by Behavior Rating Inventory of Executive Function for preschool (BRIEF-P)
Behavior and Emotion Assessment
used by Achenbach Child Behavior Checklist (CBCL)
Locations
Sponsors and contacts
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