A Phase 2 interventional study of HSK3486 and Propofol in Sedation in Intensive Care, sponsored by Haisco Pharmaceutical Group Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-05-27.
Sponsored by Haisco Pharmaceutical Group Co., Ltd. · Phase 2, Interventional, and Treatment
This is a multi-center, randomized, open-label, propofol-controlled exploratory clinical study. In this study, 20 ICU patients undergoing mechanical ventilation are expected to be enrolled and will be randomly assigned to the HSK3486 group and the propofol group in a 1:1 ratio. This study is not blinded as it is open-label.
Haisco Pharmaceutical Group Co., Ltd. is the lead sponsor of 114 studies on the registry; 48 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients having the following medical history or evidence of any of the following at screening, which may increase sedation/anesthesia risk:
Drug: HSK3486
Drug: Propofol
Loading Dose:0.1 mg/kg,Maintenance Dose:Maintenance is started at 0.3 mg/kg/h, and the dose can be adjusted up and down by 0.05-0.1 mg/kg/h.
Loading Dose:0.5 mg/kg,Maintenance Dose:Maintenance is started at1.5 mg/kg/h, and the dose can be adjusted up and down by 0.25-0.5mg/kg/h.
Mean duration of qualified sedation
the mean duration of RASS being in the range of -1 to -2 per hour during the study medication provided that no remedial medication is used
Time frame: Within 96hours of administration
Time to recovery
the time for the subject to recover from sedation to full recovery of consciousness (RASS ≥ 0) after discontinuation of drug administration.
Time frame: Within 24 hours after administration
Time to extubation
the time from intubation (applicable to patients who undergoes intubation after entering the ICU)/ICU admission (applicable to patients with intubation before entering the ICU) to extubation or the time from drug discontinuation to extubation
Time frame: Within 24 hours after administration
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Haisco Pharmaceutical Group Co., Ltd.