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

Phase 2

Completed

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

• Registration Number: NCT04867343
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-24
• Study First Submitted QC: 2021-04-29
• Study First Posted: 2021-04-30
• Study Start: 2021-06-07
• Primary Completion: 2023-08-15
• Study Completion: 2023-08-15
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-01
• Last Update Posted: 2024-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
fentanyl injection + remifentanil injection	fentanyl injection ； remifentanil injection	-
HR020602 injection	HR020602 injection	-

Primary Outcome Measures

Name	Time	Method
The success rate of anesthesia induction	Within 5 minutesafter propofol medium /long chain fat emulsion administration

Secondary Outcome Measures

Name	Time	Method
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 opioids during anesthesia maintenance period	Procedure (During the period from the beginning of anesthesia maintenance drugs to the end of anesthesia)
The incidence and severity of adverse events during the trial	Through study completion, about 3-10 days)
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)
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 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)

Trial Locations

Locations (1)

General Hospital, Tianjin Medical University; 🇨🇳 Tianjin, Tianjin, China