Clinical trial NCT03709056: A Study Evaluating the Efficacy and Safety of HSK3486
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sedation and Anesthesia for Adult Colonoscopy Procedures
Lead sponsor: Haisco Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-10-17
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

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)

Primary outcomes:
measure: Success of colonoscopy procedure
timeFrame: from the first dose of the study drug to removal of colonoscope on day 1
Secondary outcomes:
measure: Time to start of procedure
timeFrame: From first dose of study drug until insertion of colonoscope on day 1
measure: The success rate of the colonoscopy procedure
timeFrame: from the first dose of the study drug to removal of colonoscope on day 1
measure: Time to fully alert
timeFrame: from the removal of colonoscopy procedure, until the first of three consecutive MOAA/S scores of 5 on day 1
measure: Time to discharge
timeFrame: from the removal of colonoscopy procedure, until the first of three consecutive Aldrete scores of more than or equal to 9 on day 1
measure: Application of study drug and alternative medication
timeFrame: during the colonoscopy procedure on day 1
Other outcomes:
Locations:
city: Changde
country: China
facility: West China Hospital, Sichuan University
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
city: Shanghai
country: China
facility: Shanghai Fengxian District Central Hospital
city: Wenzhou
country: China
facility: The second Affiliated Hospital of Wenzhou Medical University
city: Wuhan
country: China
facility: Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
Study officials:
References: