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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.](streamdown:incomplete-link)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HR020602 injection | Experimental |
| |
| fentanyl injection + remifentanil injection | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HR020602 injection | Drug | HR020602 injection |
| |
| fentanyl injection ; remifentanil injection |
| Measure | Description | Time Frame |
|---|---|---|
| The success rate of anesthesia induction | Within 5 minutesafter propofol medium /long chain fat emulsion administration |
| Measure | Description | Time Frame |
|---|---|---|
| The success rate of anesthesia maintenance | Procedure (During the period from the beginning of anesthesia maintenance drugs to the end of anesthesia) | |
| Anesthesia recovery time | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital, Tianjin Medical University | Tianjin | Tianjin Municipality | 300052 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41545823 | Derived | Zou N, Wang X, Wang F, Zou X, Wang SY, Shangguan W, Lin X, Lei Q, Yu Y, Wang Z, Tang L, Ding Y, Zhang J. Efficacy and safety of HR020602 in combination with propofol in children receiving general anesthesia: a multicenter, phase 2 study. BMC Pediatr. 2026 Jan 16;26(1):164. doi: 10.1186/s12887-025-06495-7. |
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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.](streamdown:incomplete-link)
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| Drug |
fentanyl injection + remifentanil injection |
|
| The dosage of propofol medium/long chain fat emulsion during anesthesia maintenance period | Procedure (During the period from the beginning of anesthesia maintenance drugs to the end of anesthesia) |
| The dosage of opioids during anesthesia maintenance period | 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 | 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 | Through study completion, about 3-10 days) |
| The incidence of adverse reactions of the mental system | Within 1 hour after awakening) |
| Proportion of subjects with unstable hemodynamics (blood pressure, heart rate) | Through study completion, about 3-10 days) |