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

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: Completed
• Conditions: Used to Induce and Implement General Anesthesia in Combination With Sedative Anesthetics (Such as Propofol)
• Intervention / Treatment: Drug: HR020602 injection; Drug: fentanyl injection ； remifentanil injection

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
The success rate of anesthesia induction	Within 5 minutesafter propofol medium /long chain fat emulsion administration

Secondary Outcome Measures

Outcome Measure	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)
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)

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2021
• Primary Completion (Actual): August 15, 2023
• Study Completion (Actual): August 15, 2023

Study Registration Dates

• First Submitted: April 24, 2021
• First Submitted That Met QC Criteria: April 29, 2021
• First Posted (Actual): April 30, 2021

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Remifentanil; Fentanyl
• Other Study ID 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