Emergence delirium
Conditions
Interventions
Dose-Finding Group:Using the biased coin sequential method, initial dose 0.7 mg/kg/h. The dose for the next subject is adjusted based on the previous subject's occurrence of emergence delirium (C-CAPD
after ineffective response, the dose is increased by 0.1 mg/kg/h with 100% probability. All children receive concomitant sevoflurane (BIS target 40-60).
Experimental Group (Remimazolam + Sevoflurane):During maintenance of anesthesia, remimazolam is infused intravenously at the 90% effective dose determined from Part 1, along with sevoflurane inhalatio
Control Group (Sevoflurane + Normal Saline):During maintenance of anesthesia, sevoflurane is inhaled (1%-3%, titrated to maintain BIS 40-60) and normal saline of equal volume is infused intravenously
Sponsors
The Third Affiliated Hospital of Air Force Medical University
Eligibility
Sex/Gender
All
Age
3 Years to 6 Years
Inclusion criteria
Inclusion criteria: 1. Aged 3–6 years, either sex; 2. Scheduled for elective dental treatment of multiple primary teeth caries under general anesthesia in an outpatient setting; 3. American Society of Anesthesiologists (ASA) physical status I–III (to exclude patients with severe underlying diseases and reduce medication risk); 4. The guardian agrees to participate in the study and signs the informed consent form;
Exclusion criteria
Exclusion criteria: 1. Pre-existing behavioral disorders, developmental delay, or other congenital diseases, and use of antipsychotic medications (e.g., clozapine, risperidone, olanzapine, haloperidol, chlorpromazine, etc.); 2. Pre-existing major organ dysfunction: severe circulatory system disease (hemodynamically unstable severe arrhythmia, refractory hypertension, Kawasaki disease with giant coronary artery aneurysm (Z-score >=10.0) or coronary artery stenosis/occlusion); severe respiratory system disease (acute respiratory failure, severe chronic respiratory disease); severe hepatic insufficiency (Child-Pugh class C or meeting diagnostic criteria for pediatric acute liver failure); severe renal insufficiency (glomerular filtration rate =5.0); 5. Participation in another clinical study; 6. Inability to cooperate with the study procedures and follow-up assessments;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 90% Effective Dose (ED90) of Remimazolam for Prevention of Emergence Delirium;Incidence of Emergence Delirium in Pediatric Dental Patients Description; | — |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative Pain Score (FLACC Scale);Preoperative Anxiety Level (m-YPAS);Perioperative Adverse Events and Recovery Quality;Changes in Electroencephalogram (EEG) Power Spectral Features During Emergence; | — |
Countries
China
Contacts
Public ContactHaopeng Zhang
The Third Affiliated Hospital of Air Force Medical University
Outcome results
None listed