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

March 1, 2024 updated by: Jiangsu HengRui Medicine Co., Ltd.
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China, 300052
        • General Hospital, Tianjin Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: HR020602 injection
Drug: HR020602 injection
HR020602 injection
Active Comparator: fentanyl injection + remifentanil injection
Drug: fentanyl injection ； remifentanil injection
fentanyl injection + remifentanil injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The success rate of anesthesia induction
Time Frame: Within 5 minutesafter propofol medium /long chain fat emulsion administration
Within 5 minutesafter propofol medium /long chain fat emulsion administration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
The success rate of anesthesia maintenance
Time Frame: Procedure (During the period from the beginning of anesthesia maintenance drugs to the end of anesthesia)
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 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)
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)
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)
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)
Through study completion, about 3-10 days)
The incidence of adverse reactions of the mental system
Time Frame: Within 1 hour after awakening)
Within 1 hour after awakening)
Proportion of subjects with unstable hemodynamics (blood pressure, heart rate)
Time Frame: Through study completion, about 3-10 days)
Through study completion, about 3-10 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jiangsu HengRui Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 7, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 15, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 24, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 30, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 4, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HR020602-201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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