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| ID | Type | Description | Link |
|---|---|---|---|
| 20250690 | Other Identifier | The First Affiliated Hospital of Anhui Medical University |
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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remimazolam group | Experimental | patients who in this arm will receive remimazolam for general anesthesia induction and maintenance |
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| propofol group | Active Comparator | patients who in this arm will receive propofol for general anesthesia induction and maintenance |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam based total intravenous anesthesia | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| full-scale intelligence quotient | assessed by trained physicians, using the Wechsler Preschool and Primary Scale of Intelligence - Fourth Edition (Chinese Version) 《WPPSI-IV(CN)》 | one year after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Memory and learning ability | assessed by trained physicians, using the Wechsler Preschool and Primary Scale of Intelligence - Fourth Edition (Chinese Version) 《WPPSI-IV(CN)》 | The first to the third year after the operation |
| Language and Reading Skills |
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Inclusion Criteria:
Exclusion Criteria:
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randomized controlled clinical study
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| Propofol based general anesthesia | Drug | 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. |
|
assessed by trained physicians, using the Wechsler Preschool and Primary Scale of Intelligence - Fourth Edition (Chinese Version) 《WPPSI-IV(CN)》 |
| The first to the third year after the operation |
| Executive Function and Attention | used by Behavior Rating Inventory of Executive Function for preschool (BRIEF-P) | The first to third year after operation |
| Behavior and Emotion Assessment | used by Achenbach Child Behavior Checklist (CBCL) | The first to third year after surgery |
| Motor development | used by Movement Assessment Battery for Children-Second Edition(MABC-2) | The first to third years after surgery |