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CompletedNCT04669821Updated May 27, 2022

A Clinical Study Evaluating Sedation of Intravenous Administration of HSK3486 in ICU Patients Undergoing Long-Term Mechanical Ventilation

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

Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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.

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Conditions studied

  • Sedation in Intensive Care
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In context

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients who require tracheal intubation for mechanical ventilation, with expected sedation duration of longer than 96 h;
  2. Patients requiring a target RASS score of -1 to -2 for sedation;
  3. Aged ≥ 18 and \< 80 years old, with no gender requirement;
  4. BMI ≥ 18 kg/m2 and ≤ 30 kg/m2;
  5. The patients or their family members fully understand the objectives and significance of this study, and voluntarily participate in this clinical study and sign the informed consent form.

Exclusion criteria

Exclusion Criteria:

  1. Patients known to be allergic to eggs, soy products, opioids and their antidotes, and Propofol; patient having contraindications to Propofol, opioids and their antidotes;
  2. Patients who have received propofol for more than 3 days in the ICU or in the general ward before being transferred to the ICU before signing informed consent form;
  3. Patients having the following medical history or evidence of any of the following at screening, which may increase sedation/anesthesia risk:

    1. Cardiovascular system: New York Heart Association (NYHA) Class III and IV heart failure, Adams-stokes syndrome; acute coronary syndrome (ACS) that occurs within 6 months before screening; bradycardia requiring medication and/or heart rate ≤ 50 beats/min; a history of severe arrhythmia such as II-III degree atrioventricular block (excluding patients using pacemakers); acute and chronic myocarditis;
    2. Patients with hyperlipidemia: Defined as patients with TC ≥ 5.2 mmol/L or LDL-C ≥ 3.4 mmol/L at screening, or patients with severely increased blood pressure or blood glucose despite their blood lipid levels meeting the requirements, rendering the patients huge risk of cardiovascular diseases per the investigator's judgment; patients with acute pancreatitis;
    3. Patients with mental diseases (e.g., schizophrenia, depression) and cognitive dysfunction; grand mal epilepsy and convulsion; head injury, intracranial hypertension, cerebral aneurysm; Glasgow Coma Score (GCS) ≤ 12; SOFA Score > 9; past history of psychotropic and narcotic drug abuse; history of alcohol abuse within 3 months before screening; long-term use of psychotropic drugs;
    4. Patients with high paraplegia and general paralysis; patients with unstable hemodynamics;
    5. Severe hepatic and renal insufficiency (liver function: refer to child-pugh grade C; renal function: glomerular filtration rate eGFR ≤ 30 mL/(min•1.73 m2) [eGFR is calculated using the Modification of Diet in Renal Disease (MDRD) equation: eGFR = 175 × serum creatinine (SCr)-1.234 × age-0.179 × 0.79 (females)]; patients undergoing dialysis;
    6. Patients with an expected survival of less than 1 week;
    7. Other situations unsuitable for enrollment per the investigator's consideration.
  4. Pregnant or breastfeeding females: women or men of child-bearing potential who are unwilling to use contraception during the trial; subjects who are planning pregnancy within 1 month after the trial starts (including male subjects);
  5. Have participated in any other clinical trials within 1 month prior to screening;
  6. Other conditions that patients are judged by the investigator to be unsuitable for participating in the study.
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    HSK3486

    Drug: HSK3486

  • Active comparator
    Propofol

    Drug: Propofol

Interventions

  • DrugHSK3486

    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.

  • DrugPropofol

    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.

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What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

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Study locations

1 site
  • The First Affiliated Hospital of Xinjiang Medical University
    Xinjiang, China
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 27, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04669821
Lead sponsor
Haisco Pharmaceutical Group Co., Ltd.
Responsible party
Sponsor
First posted
Dec 17, 2020
Start date
Mar 9, 2021
Primary completion
Aug 28, 2021
Completion
Oct 9, 2021
Last update
May 27, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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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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