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

• Status: Recruiting
• Trial end date: 2021-09-30
• Target enrollment: 0
• Participant gender: All

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); the second stage is designed as a multicenter, randomized, double-blind, parallel control trial with positive drugs, which is planned to include 20 children with general anesthesia surgery in the test group and 20 children in the control group. There should be at least 15 patients in each of [2,12] and [12,18）age groups.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Treatments: Fentanyl; Remifentanil

Criteria

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.