A Study Evaluating the Efficacy and Safety of HSK3486

Study Overview
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Brief Summary
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A double-blind, randomized, active controlled, multi-center, parallel group study comparing HSK3486 with Propofol, in patients undergoing a colonoscopy.

Official Title
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A Phase IIb, Randomized, Double-blind, Propofol-controlled, Multi-center Study Evaluating the Efficacy and Safety of HSK3486 for Sedation and Anesthesia in Patients Undergoing Diagnostic Colonoscopy.

Conditions
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Sedation and Anesthesia for Adult Colonoscopy Procedures

Intervention / Treatment
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* Drug: HSK3486
* Drug: Propofol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled to undergo a diagnostic or therapeutic colonoscopy; Male or female patients, ASA grade I III, aged ≥ 18 and≤ 70; Body mass index (BMI) ≥ 18 and ≤ 30 kg/m2; the respiratory rate ≥10 and ≤24, SpO2 when inhaling ≥95%, SBP≥90mmHg, DBP≥60mmHg, HR≥55and ≤100; Patient can understand the procedure of this study and is willing to comply with study requirements. The patient can sign the ICF voluntarily. Exclusion Criteria: Patients were contraindicated in general anesthesia. Patients with a known sensitivity to propofol, opioids, naloxone, eggs, soy products or a medical condition such that these agents were contraindicated. The patient has some history or evidence of increased risk of sedation or anesthesia, such as cardiovascular disease, respiratory disease, cerebrovascular disease, gastrodintestinal disease and other system disease prior to the screening and/or baseline period. Patients with a history of drug or ethanol abuse with the past 3 months. Patients with respiratory management difficulties. Patients in receipt of any investigational drug within 30 days before screening. Patients in receipt of propofol, opioid , other sedative or anesthetic or analgesics within 72 hours before screening. Abnormal laboratory results consisting of any of the following: 1) neutrophil count≤ 1.5×109/L； 2）platelet≤ 80×109/L； 3）hemoglobin≤ 90 g/L; 4）aspartate aminotransferase≥ 1.5×ULN； 5) serum creatinine≥ 1.2×ULN. 9. Pregnant women or female patients with a positive serum or urine human chorionic gonadotropin pregnancy test at screening or baseline or lactating female patients. 10. Patients with an inability to communicate well with the investigator, or deemed unsuitable according to the investigator (in each case providing a reason)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HSK3486 0.4/0.2mg/kg ，0.5mg/kg/0.15mg/kg<br> | Drug: HSK3486<br>* HSK3486 intravenous (iv) 0.4(0.5) mg/kg for induction, and 0.2 (0.15)mg/kg top-ups for maintenance. 0.3(0.375) mg/kg for induction and 0.15 (0.113)mg/kg for maintenance in adults of 65-70 years old<br>|
| Active Comparator: Propofol 2.0/1.0mg/kg group<br> | Drug: Propofol<br>* Propofol iv 2.0 mg/kg for induction, and 1.0 mg/kg top-ups for maintenance. 1.5 mg/kg for induction and 0.75mg/kg for maintenance in adults of 65-70 years old.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success of colonoscopy procedure | Measured by completion of colonoscopy, no requirement for an alternative sedative or anesthesia drug and no requirement for more than 5 doses of study drug within any 15 minute period. | from the first dose of the study drug to removal of colonoscope on day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to start of procedure |  | From first dose of study drug until insertion of colonoscope on day 1 | 
| The success rate of the colonoscopy procedure | The number of patients who successfully completed the colonoscopy procedure accounted for the proportion of all patients in the dose group | from the first dose of the study drug to removal of colonoscope on day 1 | 
| Time to fully alert |  | from the removal of colonoscopy procedure, until the first of three consecutive MOAA/S scores of 5 on day 1 | 
| Time to discharge |  | from the removal of colonoscopy procedure, until the first of three consecutive Aldrete scores of more than or equal to 9 on day 1 | 
| Application of study drug and alternative medication | total dosages of study drug and alternative medication | during the colonoscopy procedure on day 1 |