A Phase III Study Evaluating The Efficacy and Safety of HSK3486 for Sedation or Anesthesia
|ClinicalTrials.gov Identifier: NCT03674008|
Recruitment Status : Completed
First Posted : September 17, 2018
Last Update Posted : July 5, 2019
This is a Phase III, randomized, double-blind, propofol-controlled, parallel-design, multi-center study to evaluate the efficacy and safety of HSK3486 for sedation or anesthesia in patients undergoing colonoscopy and gastroscopy.
The study will enroll approximately 280 adults. The maximum study duration is anticipated to be up to nine months.
|Condition or disease||Intervention/treatment||Phase|
|Sedation or Anesthesia||Drug: HSK3486 Drug: Propofol||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||280 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase III,Randomized, Double-blind, Propofol-controlled, Parallel-design, Multi-center Study Evaluating The Efficacy and Safety of HSK3486 for Sedation or Anesthesia in Patients Undergoing Colonoscopy and Gastroscopy|
|Actual Study Start Date :||October 9, 2018|
|Actual Primary Completion Date :||January 9, 2019|
|Actual Study Completion Date :||March 10, 2019|
HSK3486 intravenous (iv) 0.4 mg/kg for induction, and 0.2 mg/kg top-ups for maintenance.
Active Comparator: Propofol
Propofol iv 1.5 mg/kg for induction, and 0.75 mg/kg top-ups for maintenance.
- Success of colonoscopy procedure [ Time Frame: 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.
- The success rate of the gastroscopy procedure [ Time Frame: from the first dose of the study drug to removal of gastroscope on day 1 ]
- The success rate of the colonoscopy and gastroscopy procedure [ Time Frame: from the first dose of the study drug to rem oval of colonoscope and gastroscope on day 1 ]
- Time to induction of sedation or anaesthesia [ Time Frame: from the first dose of the study drug to the first MOAA/S scores≤1 on day 1 ]
- Time to start of procedure [ Time Frame: From first dose of study drug until insertion of colonoscope or gastroscope on day 1 ]
- Time to fully alert [ Time Frame: from the removal of colonoscopy or gastroscopy 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 or gastroscopy procedure, until the first of three consecutive Aldrete scores of more than or equal to 9 on day 1 ]
- Sedation/anesthesia satisfaction, satisfaction assessment of subjects, anesthesiologists, and endoscopic physicians [ Time Frame: from time to fully alert, until time to discharge on day 1 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03674008
|West China Hospital, Sichuan University|