A Study Evaluating Tolerability, Efficacy, and Safety of HSK3486 Injectable Emulsion in Patients
- Registration Number
- NCT03773042
- Lead Sponsor
- Sichuan Haisco Pharmaceutical Group Co., Ltd
- Brief Summary
A double-blind, randomized, active controlled, multi-center, parallel group study comparing HSK3486 with Propofol, in patients undergoing a colonoscopy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
Inclusion Criteria
Not provided
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description HSK3486 HSK3486 0.1mg/kg, 0.2mg/kg, 0.3mg/kg, 0.4mg/kg, 0.5mg/kg Propofol Propofol 1.0mg/kg, 2.0mg/kg
- Primary Outcome Measures
Name Time Method Rate of successful colonoscopies. From the first dose of the study drug to removal of colonoscope on day 1
- Secondary Outcome Measures
Name Time Method The success rate of the colonoscopy procedure From the first dose of the study drug to removal of colonoscope on day 1 The number of patients who successfully completed the colonoscopy procedure accounted for the proportion of all patients in the dose group
Time to fully alert From the removal of colonoscopy procedure, until the first of three consecutive MOAA/S scores of 5 on day 1 Application of study drug and alternative medication During the colonoscopy procedure on day 1 Total dosages of study drug and alternative medication
Insertion time From the first dose of study drug until insertion of colonoscope on day 1 Time to discharge From the removal of colonoscopy procedure, until the first of three consecutive MOAA/S scores of 9 on day 1 Mini-Mental State Examinations (MMSE) During the screening and the colonoscopy procedure on day 1
Trial Locations
- Locations (1)
West China Hospital, Sichuan University
🇨🇳Chengdu, Sichuan, China