Pharmacokinetics, Safety and Efficacy of HR020602 Injection in Children Undergoing General Anesthesia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-07

Study Completion Date

2023-08-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Used to Induce and Implement General Anesthesia in Combination With Sedative Anesthetics (Such as Propofol)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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HR020602 injection

Group Type EXPERIMENTAL

HR020602 injection

Intervention Type DRUG

HR020602 injection

fentanyl injection + remifentanil injection

Group Type ACTIVE_COMPARATOR

fentanyl injection ； remifentanil injection

Intervention Type DRUG

fentanyl injection + remifentanil injection

Interventions

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HR020602 injection

Intervention Type DRUG

fentanyl injection ； remifentanil injection

fentanyl injection + remifentanil injection

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No