A Study Evaluating the Efficacy and Safety of HSK3486

Phase 2

Completed

• Conditions: Sedation and Anesthesia for Adult Colonoscopy Procedures
• Interventions: Drug: HSK3486; Drug: Propofol

• Registration Number: NCT03709056
• 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

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2017-12-14
• Primary Completion: 2018-02-02
• Study Completion: 2018-08-09
• Status Verified: 2018-10
• Study First Submitted: 2018-10-08
• Study First Submitted QC: 2018-10-15
• Last Update Submitted: 2018-10-16
• Study First Posted: 2018-10-17
• Last Update Posted: 2018-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

1. Scheduled to undergo a diagnostic or therapeutic colonoscopy;
2. Male or female patients, ASA grade I~III, aged ≥ 18 and≤ 70;
3. Body mass index (BMI) ≥ 18 and ≤ 30 kg/m2;
4. the respiratory rate ≥10 and ≤24, SpO2 when inhaling ≥95%, SBP≥90mmHg, DBP≥60mmHg, HR≥55and ≤100;
5. Patient can understand the procedure of this study and is willing to comply with study requirements. The patient can sign the ICF voluntarily.

Read More

Exclusion Criteria

1. Patients were contraindicated in general anesthesia.
2. Patients with a known sensitivity to propofol, opioids, naloxone, eggs, soy products or a medical condition such that these agents were contraindicated.
3. 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.
4. Patients with a history of drug or ethanol abuse with the past 3 months.
5. Patients with respiratory management difficulties.
6. Patients in receipt of any investigational drug within 30 days before screening.
7. Patients in receipt of propofol, opioid , other sedative or anesthetic or analgesics within 72 hours before screening.
8. 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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HSK3486 0.4/0.2mg/kg ，0.5mg/kg/0.15mg/kg	HSK3486	-
Propofol 2.0/1.0mg/kg group	Propofol	-

Primary Outcome Measures

Name	Time	Method
Success of colonoscopy procedure	from the first dose of the study drug to removal of colonoscope on day 1	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.

Secondary Outcome Measures

Name	Time	Method
Time to fully alert	from the removal of colonoscopy procedure, until the first of three consecutive MOAA/S scores of 5 on day 1
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 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	during the colonoscopy procedure on day 1	total dosages of study drug and alternative medication
Time to start of procedure	From first dose of study drug until insertion of colonoscope on day 1

Trial Locations

Locations (8)

Shanghai Fengxian District Central Hospital; 🇨🇳 Shanghai, China

West China Hospital, Sichuan University; 🇨🇳 Changde, China

The Third Xiangya Hospital of Central South University; 🇨🇳 Changsha, China

Sichuan Provincial People's Hospital; 🇨🇳 Chengdu, China

The Second Xiangya Hospital of Central South University; 🇨🇳 Changsha, China

The second Affiliated Hospital of Wenzhou Medical University; 🇨🇳 Wenzhou, China

Union Hospital of Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, China

General Hospital of Ningxia Medical University; 🇨🇳 Yinchuan, China