Pediatric Anesthesia Emergence Delirium (PAED)
Conditions
Interventions
Nested propofol reference group:Propofol 1.0 mg/kg (single intravenous bolus)
Control group:An equal volume of 0.9% normal saline relative to the study drug (ciprofol or propofol).
Ciprofol group:A single intravenous bolus injection of ciprofol (HSK3486) at a dose of 0.25 mg/kg at the end of surgery.
Sponsors
Stomatological Hospital of Chongqing Medical University
Eligibility
Sex/Gender
All
Age
3 Years to 6 Years
Inclusion criteria
Inclusion criteria: 1.Children aged 3–6 years (including boundary values); 2.American Society of Anesthesiologists (ASA) physical status I or II (i.e., healthy or with mild systemic disease but well-compensated); 3.Scheduled for elective outpatient dental surgery under general anesthesia (including but not limited to dental fillings, root canal therapy, stainless steel crown restoration, and simple tooth extractions), with an expected surgical duration of >=30 minutes; 4.The legal guardian of the child is capable of reading and understanding Chinese and voluntarily signs the written informed consent form.
Exclusion criteria
Exclusion criteria: 1.Known history of allergy to propofol, lipid emulsions, ciprofol, or any components in their formulations; 2.Presence of Attention Deficit Hyperactivity Disorder (ADHD), Autism Spectrum Disorder (ASD), intellectual disability, or other neurodevelopmental or psychiatric histories that may significantly affect behavioral assessment; 3.Recent (within 2 weeks prior to screening) fever, active upper respiratory tract infection, acute asthma attack, or other severe respiratory diseases; 4.Predicted difficult airway based on preoperative anesthesia assessment (Modified Mallampati Class IV or other difficult airway features); 5.Severe hepatic or renal insufficiency (defined as Child-Pugh Class C or eGFR < 30 mL/min/1.73m^2); 6.History or suspected history of malignant hyperthermia, or a family history of malignant hyperthermia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pediatric Anesthesia Emergence Delirium Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Recovery and extubation times.;Electroencephalogram (EEG) data;Vital signs;The FLACC Pain Scale; | — |
Countries
China
Contacts
Public ContactCong Yu
Stomatological Hospital of Chongqing Medical University
Outcome results
None listed