Tonsillectomy With or Without Adenoidectomy
Conditions
Keywords
Remimazolam, Ciprofol, TIVA, PRAE
Brief summary
To observe the effects of remimazolam versus ciprofol TIVA on PRAE in pediatric tonsillectomy and adenoidectomy.
Detailed description
To observe the effects of remimazolam versus ciprofol TIVA on PRAE in pediatric tonsillectomy and adenoidectomy, aiming to enhance surgical safety and improve postoperative outcomes in pediatric patients.
Interventions
DRUGRemimazolam
remimazolam induction (0.3-0.5 mg/kg) + maintenance (1-3 mg/kg/h)
DRUGPropofol
Anesthesia induction (2-3 mg/kg) + Anesthesia maintenance (6-10 mg/kg/h)
DRUGCiprofol
Anesthesia induction (0.4-0.5 mg/kg) + Anesthesia maintenance (0.8-1.2 mg/kg/h)
Sponsors
Tongji Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Aged 2-12 years * ASA physical status I-II * Body mass index (BMI): 14-28 kg/m² * Scheduled for elective tonsillectomy with or without adenoidectomy * Signed informed consent by legal guardian(s) and assent by children (≥8 years old)
Exclusion criteria
* History of severe pulmonary diseases (e.g., asthma, bronchiectasis, severe OSA) * Previous episodes of significant PRAEs * Documented drug allergies (e.g., to remimazolam, propofol, or ciprofol) * Comorbidities including: Uncorrected congenital heart disease, neuromuscular disorders, Developmental delay, Abnormal hepatic/renal function * Preoperative moderate-to-severe respiratory infections requiring surgery postponement * Recent participation in other clinical trials
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of perioperative respiratory adverse events | 5days | The perioperative respiratory adverse events including: laryngospasm, bronchospasm, severe cough, oxygen desaturation, airway obstruction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Emergence time | 1 day | From anesthetic discontinuation to eye opening on command |
| Extubation time | 1 day | From anesthetic discontinuation to endotracheal tube removal |
| Anesthesia duration | 1 day | From anesthesia induction to discontinuation of anesthetics |
| The modified Aldrete score | 1 day | Upon admission to the PACU, the child was assessed using the modified Aldrete score, which ranges from 0 to 10. A higher score indicates a better recovery status. |
| doses of drugs | 24 hours | Total sedative/analgesic consumption |
| PACU stay duration | 1 day | From PACU admission to meeting discharge criteria |
Countries
China
Contacts
Primary ContactPu Zhou
Backup ContactAihua Du
Outcome results
None listed