Clinical trial NCT04867343: Pharmacokinetics, Safety and Efficacy of HR020602 Injection in Children Undergoing General Anesthesia
Official title: Pharmacokinetics, Safety and Efficacy of HR020602 Injection in Children Undergoing General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Used to Induce and Implement General Anesthesia in Combination With Sedative Anesthetics (Such as Propofol)
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-04-30
Enrollment: 70
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. 2 years old ≤age\<18 years old, regardless of gender;
2. General anesthesia is planned;
3. ASA score grade I \~ II; 4）Able to sign the informed consent.

Exclusion Criteria:

1. Children with general anesthesia contraindications;
2. With diseases that are not suitable for the study in the scheme;
3. Abnormal liver and kidney function in screening stage;
4. Abnormal coagulation function;
5. Serum electrolyte abnormality;
6. Subjects intolerant or allergic to the study drugs;
7. Recently received other narcotic drugs or other drugs that affect the metabolism of study drugs;
8. The child thought to be unsuitable for the study, as determined by the investigator.

Primary outcomes:
measure: The success rate of anesthesia induction
timeFrame: Within 5 minutesafter propofol medium /long chain fat emulsion administration
Secondary outcomes:
measure: The success rate of anesthesia maintenance
timeFrame: Procedure (During the period from the beginning of anesthesia maintenance drugs to the end of anesthesia)
measure: Anesthesia recovery time
timeFrame: 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)
measure: The dosage of propofol medium/long chain fat emulsion during anesthesia maintenance period
timeFrame: Procedure (During the period from the beginning of anesthesia maintenance drugs to the end of anesthesia)
measure: The dosage of opioids during anesthesia maintenance period
timeFrame: Procedure (During the period from the beginning of anesthesia maintenance drugs to the end of anesthesia)
measure: Clearance rate (CL), apparent volume of distribution (V) and inter individual variation (CV%) of parameters
timeFrame: PK blood collection are to be performed at 5 time points during Day 1-Day 2)
measure: The incidence and severity of adverse events during the trial
timeFrame: Through study completion, about 3-10 days)
measure: The incidence of adverse reactions of the mental system
timeFrame: Within 1 hour after awakening)
measure: Proportion of subjects with unstable hemodynamics (blood pressure, heart rate)
timeFrame: Through study completion, about 3-10 days)
Other outcomes:
Locations:
city: Tianjin
country: China
facility: General Hospital, Tianjin Medical University
state: Tianjin
Study officials:
References: