Emergence delirium
Conditions
Interventions
Remimazolam group:Anesthesia was induced and maintained with remimazolam besylate. Induction dose: 0.45–0.60 mg/kg for children aged 3–6 years and 0.45–0.60 mg/kg for children aged 6–12 years
maintenance dose: 1–2 mg/kg/h. Additionally, both groups received intravenous fentanyl (3 µg/kg) and vecuronium (1 mg/kg), along with intravenous remifentanil infused at 0.1–0.5 µg/kg/min and inhalati
The propofol group:Anesthesia was induced and maintained with propofol. Induction dose: 2.5 mg/kg
maintenance dose: 4–10 mg/kg/h. Additionally, both groups received intravenous fentanyl (3 µg/kg) and vecuronium (1 mg/kg), along with intravenous remifentanil infused at 0.1–0.5 µg/kg/min and inhalat
Sponsors
The First Affiliated Hospital of Xiamen University
Eligibility
Sex/Gender
All
Age
3 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1. Children scheduled for elective non-cardiac, non-neurosurgical, and non-hepatic surgery under general anesthesia. 2. Operative time <= 2 hours. 3. Aged 3-12 years. 4. American Society of Anesthesiologists (ASA) I or II.
Exclusion criteria
Exclusion criteria: 1. Children with systemic diseases, including: cardiovascular disorders; respiratory diseases (e.g., upper respiratory tract infection, asthma); hepatic dysfunction, defined as alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >= 1.5 times the upper limit of normal (ULN), or total bilirubin exceeding ULN; renal dysfunction, defined as creatinine and/or urea nitrogen levels above ULN. 2. Children with psychiatric disorders or cognitive impairment. 3. Children anticipated to have difficult airway management. 4. Children with severe failure to thrive. 5. Children with known or suspected allergy or contraindication to any drugs in the protocol. 6. Children expected to have difficult airway management. 7. Patients with severe growth developmental delay. 8. Children with known or suspected hypersensitivity or contraindications to any component of the investigational product or protocol-specified standard medications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Emergence delirium; | — |
Secondary
| Measure | Time frame |
|---|---|
| Emergence agitation;Moderate-to-severe postoperative pain;Recovery time;Extubation time;Time to Aldrete score >= 9;Perioperative vital Signs; | — |
Countries
China
Contacts
Public ContactWu Limei
The First Affiliated Hospital of Xiamen University
Outcome results
None listed