NCT04048811

A Clinical Trial Evaluating the Efficacy and Safety of HSK3486 Injectable Emulsion in Elective Surgery Patients

A Multi-Center, Randomized, Open-Label, Positive-Controlled Phase II Clinical Trial Evaluating the Efficacy and Safety of HSK3486 Injectable Emulsion for Induction and Maintenance of General Anesthesia in Elective Surgery Patients.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Sichuan Haisco Pharmaceutical Group Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, randomized, open-label, positive-controlled (propofol) phase II clinical trial. The study plans to enroll approximately 46 eligible subjects. Among them, 40 subjects will be randomly assigned to HSK3486 treatment group (30 cases) and propofol control group (10 cases) in a ratio of 3:1. The subjects will be enrolled competitively at all study sites. Upon enrollment of the 40 subjects, 6 more subjects will be enrolled by West China Hospital of Sichuan University. These 6 subjects will not be randomized, but will directly enter into propofol induction + HSK3486 maintenance group for study.

Conditions

• Induction and Maintenance of General Anesthesia

Interventions

Type	Name	Description
DRUG	HSK3486	The induction dose is 0.4mg/mg. The initial maintenance dose of the first 6 subjects is 1 mg/kg/h. For the subsequent enrolled subjects, the investigator could adjust the subsequent initial maintenance dose according to the dose response of the first 6 subjects, so as to explore the optimal initial maintenance dose. The range of the initial maintenance dose is 1 (± 0.5) mg/kg/h, i.e. the minimum initial maintenance dose should not be less than 0.5 mg/kg/h, and the maximum should not be more than 1.5 mg/kg/h.
DRUG	Propofol	The induction dose is 2.0mg/mg. The initial maintenance dose of the first 2 subject is 5 mg/kg/h. For the subsequent enrolled subjects, the investigator could adjust the subsequent initial maintenance dose according to the dose response of the first 2 subjects, so as to explore the optimal initial maintenance dose. The adjustment range of the initial maintenance dose is 5 (± 2.5) mg/kg/h, i.e. the minimum initial maintenance dose should not be less than 2.5 mg/kg/h, and the maximum should not be more than 7.5 mg/kg/h.
DRUG	Propofol HSK3486	The induction dose of Propofol is 2.0mg/mgThe initial maintenance dose of HSK3486 is fixed at 1 mg/kg/h, without adjustment.

Timeline

• Start date: 2019-12-09
• Primary completion: 2020-05-23
• Completion: 2020-06-22
• First posted: 2019-08-07
• Last updated: 2020-12-17

Locations

1 site across 1 country: China