childern disease
Conditions
Interventions
Group 1 :Subjects received intravenous infusion of remazolam: initial rate of 5 mg/kg/h infusion over 5 minutes, followed by 1.5 mg/kg/h infusion over 55 minutes
Sponsors
The Second Affiliated Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
2 Years to 6 Years
Inclusion criteria
Inclusion criteria: 1. The age is 2-6 years, and the gender is not limited; 2. The ASA classification is I or II; 3. The weight is within the normal range, 15 kg/m2 < BMI < 18 kg/m2; 4. Planned for children undergoing tracheal intubation or laryngeal mask placement under general anesthesia, the estimated operation time is more than 2 hours; 5. The parents or legal guardians of the children voluntarily participated in this trial and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Paediatric population in need of special care or supervision by courts/social welfare institutions; 2. Children who had general anesthesia within 14 days before randomization; 3. Complicated with severe cardiovascular diseases; 4. Children with abnormal liver function, ALT and/or AST > 1.5 times the upper limit of normal; children with total bilirubin exceeding the upper limit of normal value; children with abnormal renal function and creatinine and/or urea nitrogen above the upper limit of normal; 5. Children with anemia identified by the investigator as needing treatment; 6. Children with mental system diseases and cognitive dysfunction; children with a history of epilepsy; 7. Children with past behavior abnormalities after medication; 8. Children with acute angle-closure glaucoma; 9. Children judged to have difficulty managing respiratory tract: modified Marschner score of grade III or IV; 10. Children who have participated in clinical trials of other drugs (received experimental drugs) within 3 months prior to the screening period; 11. Known or suspected allergies or contraindications to the drug components or processes specified in the regimen; 12. Other conditions that the investigator judged unsuitable for participation in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The plasma concentration of remazolam at each time point;Various pharmacokinetic parameters; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hemodynamic effects of remazolam;Dose-response relationship of remazolam;Restlessness score and sedation score during recovery;Time to wake up and time to recover directional force;Safety and tolerability assessment; | — |
Countries
China
Contacts
Public ContactLiu Huacheng
The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Outcome results
None listed