Children disease
Conditions
Interventions
control group:propofol
Sponsors
the Second Affiliated Hospital of WenZhou Medical University
Eligibility
Sex/Gender
All
Age
3 Years to 6 Years
Inclusion criteria
Inclusion criteria: 1. 3-6 years old, and the gender is not limited; 2. ASA is graded I-II; 3. 14kg/m^2<BMI<25kg/m^2; 4. Non-cardiothoracic, non-brain, non-liver elective surgery children who need to undergo tracheal intubation under general anesthesia; 5. The parents or legal guardians of the children voluntarily participate in this trial and sign the informed consent; 6. Meet the weight standard: (1) Three-year-old boy/girl: 13.1kg~16.4kg/12.7kg~15.8kg; (2) Four-year-old boy/girl: 14.9kg~21.0kg/14.4kg~20.5kg; (3) Five-year-old boy/girl: 16.9kg~24.4kg/16.2kg~23.5kg; (4) Six-year-old boy/girl 18.7kg~28.0kg/17.9kg~26.7kg.
Exclusion criteria
Exclusion criteria: 1. Pediatric populations requiring special care or court/social welfare agency supervision; 2. Subjects who have received general anesthesia within 14 days before randomization; 3. Those who plan to undergo total intravenous anesthesia before entering the operating room and need to combine other anesthesia methods, such as inhalation anesthesia, epidural anesthesia, subarachnoid anesthesia or regional block, etc. 4. Combined with serious cardiovascular system diseases; 5. Test children with abnormal liver function, ALT and/or AST > 1.5 times the upper limit of normal value; children with total bilirubin exceeding the upper limit of normal value; abnormal renal function, creatinine and/or urea nitrogen higher than the upper limit of normal value of the patients tested; 6. Children with anemia judged by the investigator to need treatment; 7. Children with mental system diseases and cognitive impairment; children with a history of epilepsy; 8. Subjects who have experienced abnormal behavior after medication in the past; 9. Children with acute angle-closure glaucoma; 10. Children who are judged to have difficulty in airway management: the modified Markov score is grade III or grade IV; 11. Children who have participated in clinical trials of other drugs (received trial drugs) within 3 months before the screening period; 12. Known or suspected use of the various components of the study drug or the procedures prescribed in the protocol (sufentanil citrate injection, cisatracurium injection, remifentanil hydrochloride for injection, ketone Allergy or contraindications to tromethamine injection, neostigmine methyl sulfate injection, and atropine sulfate injection); 13. Other situations judged by the investigator to be inappropriate to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| proportion of the successful induction of anesthesia;proportion of the successful maintenance of anesthesia; | — |
Secondary
| Measure | Time frame |
|---|---|
| time to awakening;Emergence Agitation Score (PAED);FLACC Pain Assessment Scale;extubation time;Time from start of study drug administration to loss of consciousness;proportion of using additional sedative drugs During Induction of anesthesia;proportion of using remedial sedative drugs in PACU;Anesthesia satisfaction score;Postoperative Behavioral Questionnaire Score;Time between discontinuation of study drug and Aldrete score of >=9; | — |
Countries
China
Contacts
Public ContactLiu Huacheng
The Second Affiliated Hospital of Wenzhou Medical Universtiy
Outcome results
None listed