HSK3486
DrugHSK3486 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
NCT Number: NCT03709056
A double-blind, randomized, active controlled, multi-center, parallel group study comparing HSK3486 with Propofol, in patients undergoing a colonoscopy.
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Notify Me18 year–70 year
All sexes
Interventional
Phase 2
West China Hospital, Sichuan University, Changde, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: From first dose of study drug until insertion of colonoscope on day 1
Time frame: 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 frame: from the removal of colonoscopy procedure, until the first of three consecutive MOAA/S scores of 5 on day 1
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
Time frame: during the colonoscopy procedure on day 1
total dosages of study drug and alternative medication
Sichuan Haisco Pharmaceutical Group Co., Ltd
Industry
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.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.