Status:
COMPLETED
Pharmacokinetics, Safety and Efficacy of HR020602 Injection in Children Undergoing General Anesthesia
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Used to Induce and Implement General Anesthesia in Combination With Sedative Anesthetics (Such as Propofol)
Eligibility:
All Genders
2-18 years
Phase:
PHASE2
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 s...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 15 2023
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04867343
Start Date
June 7 2021
End Date
August 15 2023
Last Update
March 4 2024
Active Locations (1)
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1
General Hospital, Tianjin Medical University
Tianjin, Tianjin Municipality, China, 300052