Surgery for Pediatric Patients
Conditions
Interventions
Dexmedetomidine Nasal Spray Group (Experimental group) :Dexmedetomidine nasal spray. Intranasal administration was based on body weight (one puff for 10.7kg<= body weight <19.4kg and two sprays for 19
Normal Saline Group (Control group):Saline nasal spray identical in appearance. The administration method, timing, and number of sprays are identical to those in the experimental group.
Sponsors
Shaoxing People's Hospital
Eligibility
Sex/Gender
All
Age
2 Years to 6 Years
Inclusion criteria
Inclusion criteria: 1. Children aged between 2 and 6 years old who are scheduled to undergo various surgeries under general anesthesia, such as pediatric general surgery (e.g., inguinal hernia repair, appendectomy, etc.), pediatric urology surgery (e.g., circumcision, cryptorchidism descent fixation, etc.), and pediatric otolaryngology surgery (e.g., adenoidectomy, tonsillectomy, etc.); 2. American Society of Anesthesiologists (ASA) classification of grades I - II; 3. Body mass index ranging from 10.7 to 28 kg/m^2; 4. The parents of the children sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. There are underlying diseases that may affect the research results, such as severe cardiopulmonary dysfunction, liver and kidney dysfunction, and neurological disorders; 2. Allergic to dexmedetomidine or other related drugs; 3. Had a history of upper respiratory tract infection within the recent 1 week before the surgery; 4. Abnormal nasal anatomy or nasal diseases (such as deviation of the nasal septum, sinusitis, etc.) that affect drug absorption; 5. History of drug abuse or mental illness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| preoperative modified Ramsay Sedation Scale (RSS) score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Frankl Behavior Rating Scale score;Parental Separation Anxiety Scale (PSAS) score;modified Yale Preoperative Anxiety Scale (m-YPAS) score;assessment of mask acceptance;Induction Compliance Checklist (ICC) score;perioperative adverse reactions;perioperative medication profile;perioperative vital signs;Surgeon's Satisfaction Score with the Procedure;Time to Emergence (from discontinuation of the drug to the child opening eyes on command);Length of Stay in the PACU;Time to Extubation;PAED Scale (Pediatric Anesthesia Emergence Delirium Scale);FLACC Scale (Face, Legs, Activity, Cry, Consolability Scale); | — |
Countries
China
Contacts
Public ContactChen Zhonghua
Shaoxing People's Hospital
Outcome results
None listed