Adenotonsillar Hypertrophy
Conditions
Keywords
remimazolam, neurodevelopment, propofol, children, tonsillectomy
Brief summary
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.
Interventions
For 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.
For 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.
Sponsors
The First Affiliated Hospital of Anhui Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
randomized controlled clinical study
Eligibility
Sex/Gender
ALL
Age
3 Years to 6 Years
Healthy volunteers
No
Inclusion criteria
1. Age: 3-6 years old; 2. Planned to undergo elective non-neurological, non-cardiac, and non-liver surgery under general anesthesia (abdominal surgery, orthopedic surgery, urological surgery, otolaryngological surgery, etc.); 3. Expected anesthesia duration to be more than 30 minutes; 4. ASA classification I-II; 5. BMI 14-25 kg/m2; 6. Postoperative plan not to be admitted to ICU; 7. Parents or legal guardians of the child have given informed consent; 8. Capable of communicating in Chinese.
Exclusion criteria
1. Those who were exposed to general anesthetic drugs during infancy or in the late pregnancy of the mother; 2. 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.; 3. Patients with severe liver dysfunction (Child-Pugh C grade); 4. Patients with severe kidney dysfunction (requiring dialysis before surgery); 5. Patients with a history of congenital heart disease requiring surgery or drug treatment; 6. Those allergic to the study drugs remimazolam or propofol; 7. Any known neural damage, such as cystic periventricular leukomalacia or grade 3 or 4 intraventricular hemorrhage; 8. Social or geographical factors that may lead to postoperative loss of follow-up; 9. Planned to undergo two surgeries within 7 days after the surgery; 10. Those currently participating in other clinical trials; 11. Those receiving special care or living in social welfare institutions or any other factors that may affect their ability to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| full-scale intelligence quotient | one year after surgery | assessed by trained physicians, using the Wechsler Preschool and Primary Scale of Intelligence - Fourth Edition (Chinese Version) 《WPPSI-IV(CN)》 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Memory and learning ability | The first to the third year after the operation | assessed by trained physicians, using the Wechsler Preschool and Primary Scale of Intelligence - Fourth Edition (Chinese Version) 《WPPSI-IV(CN)》 |
| Language and Reading Skills | The first to the third year after the operation | assessed by trained physicians, using the Wechsler Preschool and Primary Scale of Intelligence - Fourth Edition (Chinese Version) 《WPPSI-IV(CN)》 |
| Executive Function and Attention | The first to third year after operation | used by Behavior Rating Inventory of Executive Function for preschool (BRIEF-P) |
| Behavior and Emotion Assessment | The first to third year after surgery | used by Achenbach Child Behavior Checklist (CBCL) |
| Motor development | The first to third years after surgery | used by Movement Assessment Battery for Children-Second Edition(MABC-2) |
Outcome results
None listed