Tonsillectomy and adenoidectomy,
Conditions
Interventions
DEX+IMV (Dexmedetomidine + Individualized Maternal Voice):In the DEX group (active drug group), immediately after tracheal intubation, dexmedetomidine diluted to 5 µg/mL was continuously infused via a
DEX+PlaceboV (Dexmedetomidine + Placebo Voice):In the DEX group (active drug group), immediately after tracheal intubation, dexmedetomidine diluted to 5 µg/mL was continuously infused via an infusion
Saline+IMV (Normal Saline + Individualized Maternal Voice):In the Saline group (placebo group), an equal volume of 0.9% normal saline was infused at the same time point. Simultaneously, in the IMV gro
Saline+IMV (Normal Saline+Placebo Voice):In the Saline group (placebo group), an equal volume of 0.9% normal saline was infused at the same time point. Simultaneously, in the PlaceboV group (placebo v
Sponsors
The First Affiliated Hospital of Kunming Medical University
Eligibility
Sex/Gender
All
Age
3 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1. Children scheduled for elective tonsillectomy with or without adenoidectomy; 2. Age: 3 to 12 years old (inclusive); 3. ASA Physical Status Classification: Class I or II; 4. Legal guardians are fluent in Chinese and can cooperate to complete high-quality individualized voice recordings.
Exclusion criteria
Exclusion criteria: 1. Known allergy to dexmedetomidine or any excipient in its formulation; 2. Presence of neurological or developmental disorders that may affect assessment (e.g., autism spectrum disorder, intellectual disability, developmental delay, history of epilepsy); 3. Severe hearing impairment; 4. Use of sedatives, anxiolytics, or antipsychotic medications within 1 week prior to surgery; 5. Severe cardiac, pulmonary, hepatic (Child-Pugh Class C), or renal insufficiency (estimated creatinine clearance 60 or polysomnography (PSG) with an apnea-hypopnea index (AHI) > 10 events/hour; 7. Personal or family history of malignant hyperthermia; 8. Airway assessment indicating a difficult airway (Mallampati classification >= Grade III).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The severity of emergence agitation, defined as the highest PAED score recorded within the first 30 minutes after extubation.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of EA (defined as a PAED score >= 12).;Extubation Time;PACU length of stay;Postoperative pain scores;Utilization rate of rescue analgesic/sedative medications;Incidence of postoperative adverse events (e.g., PONV, cardiorespiratory events); | — |
Countries
China
Contacts
Public ContactYu Fang;Xiong Zhang
The First Affiliated Hospital of Kunming Medical University
Outcome results
None listed