oral diseases
Conditions
Interventions
Remimazolam group:The initial dose of remimazolam was 0.3mg/kg, and 0.1mg/kg remimazolam was added which met MOAA/S=4 points
Midazolam group:The initial dose of midazolam group was 0.05mg /kg, and 0.01mg/kg midazolam was added which met MOAA/S=4 points
Sponsors
The Third Affiliated Hospital of Air Force Medical University
Eligibility
Sex/Gender
All
Age
3 Years to 7 Years
Inclusion criteria
Inclusion criteria: 1. Patients receiving tooth extraction under sedation; 2. Aged 3 to 7 years; 3. 18 kg/m^2 = BMI =30 kg/m^2; 4. ASA I - II; 5. Informed consent got from patients.
Exclusion criteria
Exclusion criteria: 1 Children with history of neurological diseases and disability; 2 Children with history of respiratory or airway related diseases; 3. Children with difficult airway (Modified Mallampati score IV); 4. With severe systemic diseases and ASA level above ?; 5. With hepatic and kidney insufficiency; 6. Children with closed and open angle glaucoma 7. Known allergy to benzodiazepines or local anesthesia; 8. Children refusing treatment under sedation; 9. Children participating other clinical trials within the past three month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sedation success rate;Times to readiness for discharge after the end of the procedure;Complications related to medication; | — |
Secondary
| Measure | Time frame |
|---|---|
| Frankl Scale;Local anesthesia puncture and intraoperative pain VAS score;Time to peak sedation after administration of the first dose of medication;Time to local anesthesia after administration of the first dose of medication;Times to fully alert (first of 3 MOAA/S scores of 5 after end of the procedure) ;Times to fully alert (first of 3 MOAA/S scores of 5 after administration of the last dose of medication);Times to readiness for discharge after the last dose of the medication;Fluctuation of MOAA/S;Satisfaction of patients, dentists and anesthesiologists;Recovery quality evaluation;adverse events during the procedure; | — |
Countries
China
Contacts
Public ContactHui ZHANG
The Third Affiliated Hospital of Air Force Medical University
Outcome results
None listed