Hypertrophy of the tonsils with hypertrophy of the adenoids
Conditions
Interventions
R1 Group (Remazolam 0.1 mg/kg Group):Intravenous push of remazolam 0.1 mg/kg at the end of surgery during skin suturing
R2 Group (Remazolam 0.2 mg/kg Group):Intravenous push of remazolam 0.2 mg/kg at the end of surgery during skin suturing
R3 Group (Remazolam 0.3 mg/kg Group):Intravenous push of remazolam 0.3 mg/kg at the end of surgery during skin suturing
P Group (Placebo Group):Intravenous push of equivalent volume of normal saline at the end of surgery during skin suturing
Sponsors
Affiliated Hospital of North Sichuan Medical College
Eligibility
Sex/Gender
All
Age
3 Years to 6 Years
Inclusion criteria
Inclusion criteria: 1. Age between 3 and 6 years; 2. American Society of Anesthesiologists (ASA) physical status classification I or II; 3. Scheduled to undergo elective adenoidectomy and/or tonsillectomy under general anesthesia.
Exclusion criteria
Exclusion criteria: 1. Allergy to remimazolam or benzodiazepine drugs; 2. History of neurological or psychiatric disorders (e.g., epilepsy, autism, developmental delay); 3. Recent upper respiratory tract infection with fever within 2 weeks; 4. Severe hepatic or renal dysfunction; 5. Severe obstructive sleep apnea (apnea-hypopnea index = 5.0); 6. Abnormal cardiac function; 7. Bradycardia (heart rate < 60 beats per minute); 8. Long-term use of sedatives, analgesics, or anticonvulsants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of emergence delirium; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Severe Emergence Delirium;Extubation Time;Emergence Time;FLACC (Face, Legs, Activity, Cry, Consolability) scale was used to assess postoperative pain intensity in pediatric patients at 0, 5, 10, 20, and 30 minutes after emergence from anesthesia.;PACU stay time;Pain intensity, MAP, SpO2, and HR were measured every 10 minutes for 30 minutes after extubation.;Proportion of children requiring rescue analgesia (sufentanil) and management of emergence delirium (propofol).;Parental satisfaction was self-reported 24 hours postoperatively using the Numeric Rating Scale (NRS, range 0-10).;Incidence of Adverse Events; | — |
Countries
China
Contacts
Public ContactPang Yong
Department of Anesthesiology, Affiliated Hospital of North Sichuan Medical College
Outcome results
None listed