Used to Induce and Implement General Anesthesia in Combination With Sedative Anesthetics (Such as Propofol)Phase 2NCT04867343

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

A Phase 2 study testing HR020602 injection and fentanyl injection ； remifentanil injection in people with Used to Induce and Implement General Anesthesia in Combination With Sedative Anesthetics (Such as Propofol), run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 2 to 18 years
Conditions the study is for: Used to Induce and Implement General Anesthesia in Combination With Sedative Anesthetics (Such as Propofol)
What is being tested?: HR020602 injection and fentanyl injection ； remifentanil injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 1 siteChina
Study dates: 7 Jun 2021to 15 Aug 2023
Phase: Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

General Hospital, Tianjin Medical University
Tianjin, Tianjin Municipality, 300052

Other trials in China

About this study

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.

Conditions: Used to Induce and Implement General Anesthesia in Combination With Sedative Anesthetics (Such as Propofol)
Being tested: HR020602 injection, fentanyl injection ； remifentanil injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HR020602 injectionDrug
HR020602 injection
fentanyl injection ； remifentanil injectionDrug
fentanyl injection + remifentanil injection

Study groups in NCT04867343
Study group	Role	What they receive
HR020602 injection	Experimental	Not described Receives: Drug: HR020602 injection
fentanyl injection + remifentanil injection	Active comparator	Not described Receives: Drug: fentanyl injection ； remifentanil injection

What is being measured

The primary outcome is the main question the study is designed to answer.

The success rate of anesthesia induction
Measured: Within 5 minutesafter propofol medium /long chain fat emulsion administration

Secondary outcomes (8)

The success rate of anesthesia maintenance
Measured: Procedure (During the period from the beginning of anesthesia maintenance drugs to the end of anesthesia)
Anesthesia recovery time
Measured: 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
Measured: Procedure (During the period from the beginning of anesthesia maintenance drugs to the end of anesthesia)
The dosage of opioids during anesthesia maintenance period
Measured: 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
Measured: 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
Measured: Through study completion, about 3-10 days)
The incidence of adverse reactions of the mental system
Measured: Within 1 hour after awakening)
Proportion of subjects with unstable hemodynamics (blood pressure, heart rate)
Measured: Through study completion, about 3-10 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Jun 202115 Aug 2023

First posted30 Apr 2021
Study start7 Jun 2021
Primary completion15 Aug 2023
Study completion15 Aug 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Used to Induce and Implement General Anesthesia in Combination With Sedative Anesthetics (Such as Propofol)Studies of the same condition, open and under way.
More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04867343
Sponsor's protocol ID: HR020602-201
Status last verified: Mar 2024
First submitted: 24 Apr 2021
Last updated: 4 Mar 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 41545823