None
Conditions
Interventions
Placebo group:Apply saline nasal spray before surgery
Dexmedetomidine hydrochloride nasal spray group:Preoperative application of dexmedetomidine hydrochloride nasal spray
Sponsors
Beijing Childrens Hospital,Capital Medical University
Eligibility
Sex/Gender
All
Age
2 Years to 6 Years
Inclusion criteria
Inclusion criteria: 1.ASA I-II; 2.Age 2-6 years; 3.Weight 10kg-30kg; 4.General anesthesia surgery, with tracheal intubation or laryngeal mask airway for mechanical ventilation during the operation; 5.The estimated duration of the surgery is less than 2 hours; 6.The guardian agrees to use the study drug and voluntarily signs the informed consent form;
Exclusion criteria
Exclusion criteria: 1.Preoperative assessment indicates that children unsuitable for nasal spray administration are those presenting with symptoms such as prolonged nasal congestion, rhinorrhea, epistaxis, as well as conditions affecting drug absorption, including abnormal nasal anatomy and nasal mucosal abnormalities. 2.Children with psychiatric disorders and cognitive impairments; children with a medical history of epilepsy; 3.Pediatric patients with congenital cardiopulmonary disorders complicated by arrhythmias (e.g., atrioventricular block, bradycardia); 4.Pediatric patients with airway hyperresponsiveness, such as those previously diagnosed by researchers as having conditions posing safety risks, including asthma or sleep apnea syndrome; 5.Subjects exhibiting abnormal liver function, characterized by ALT and/or AST levels exceeding 1.5 times the upper limit of the normal range; pediatric patients with total bilirubin levels surpassing the upper limit of the normal range; 6.Pediatric patients with a history of difficult airway or with potential difficult airway conditions; 7.Pediatric patients with a prior history of hypersensitivity to drug ingredients or components, including dexmedetomidine, propofol, and opioids; 8.Recent administration of sedative medications (such as midazolam, ketamine, and dexmedetomidine); 9.History of multiple surgical anesthesias;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of postoperative delirium during the recovery period; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of postoperative sore throat;Time of separation between mother and child after drug administration;FLACC pain score during the awakening period;Wake-up time;Extubation time;The time taken to achieve a Ramsay score of >3 after administration of the drug;Incidence of adverse events after perioperative medication administration;Preoperative propofol rescue and dosage;Intraoperative opioid dosage;Success rate of mother-child separation;The proportion of patients achieving a Ramsay score >3 within 30 minutes after administration;Dosage of rescue medication in PACU;Incidence of severe delirium during the awakening phase (PAED > 12 points);PACU stay duration;PAED delirium score during the awakening phase; | — |
Countries
China
Contacts
Public ContactGao Jia
Beijing Childrens Hospital,Capital Medical University
Outcome results
None listed