This study is divided into two stages: the first stage is a dose verification trial, with a multicenter, open, single arm trial design, which is planned to enroll 10 children with general anesthesia surgery (all using HR020602 injection); If the result shows that the dose is low, 10 children under general anesthesia will be included again for higher dose verification.The second stage is designed as a multicenter, randomized, double-blind, parallel control trial with positive drugs, which is planned to include 25 children with general anesthesia surgery in the test group and 25 children in the control group. There should be at least 20 patients in each of \[2,12\] and \[12,18）age groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
70
HR020602 injection
fentanyl injection + remifentanil injection
General Hospital, Tianjin Medical University
Tianjin, Tianjin Municipality, China
The success rate of anesthesia induction
Time frame: Within 5 minutesafter propofol medium /long chain fat emulsion administration
The success rate of anesthesia maintenance
Time frame: Procedure (During the period from the beginning of anesthesia maintenance drugs to the end of anesthesia)
Anesthesia recovery time
Time frame: The time from stopping using anesthetic drugs (propofol medium/long-chain fat emulsion) to the time when the subject wakes up (opening eyes as instructed)
The dosage of propofol medium/long chain fat emulsion during anesthesia maintenance period
Time frame: Procedure (During the period from the beginning of anesthesia maintenance drugs to the end of anesthesia)
The dosage of opioids during anesthesia maintenance period
Time frame: Procedure (During the period from the beginning of anesthesia maintenance drugs to the end of anesthesia)
Clearance rate (CL), apparent volume of distribution (V) and inter individual variation (CV%) of parameters
Time frame: PK blood collection are to be performed at 5 time points during Day 1-Day 2)
The incidence and severity of adverse events during the trial
Time frame: Through study completion, about 3-10 days)
The incidence of adverse reactions of the mental system
Time frame: Within 1 hour after awakening)
Proportion of subjects with unstable hemodynamics (blood pressure, heart rate)
Time frame: Through study completion, about 3-10 days)
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