A double-blind, randomized, active controlled, multi-center, parallel group study comparing HSK3486 with Propofol, in patients undergoing a colonoscopy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
94
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
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.
West China Hospital, Sichuan University
Changde, China
The Second Xiangya Hospital of Central South University
Changsha, China
The Third Xiangya Hospital of Central South University
Changsha, China
Sichuan Provincial People's Hospital
Chengdu, China
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.
Time frame: from the first dose of the study drug to removal of colonoscope on day 1
Time to start of procedure
Time frame: 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
Time frame: from the first dose of the study drug to removal of colonoscope on day 1
Time to fully alert
Time frame: from the removal of colonoscopy procedure, until the first of three consecutive MOAA/S scores of 5 on day 1
Time to discharge
Time frame: 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
Time frame: during the colonoscopy procedure on day 1
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Shanghai Fengxian District Central Hospital
Shanghai, 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