A Study Evaluating Sedation of Intravenous Administration of HSK3486 Injectable Emulsion in ICU Patients Undergoing Mechanical Ventilation

NCT04620031 | Completed Phase 3

• 1 other identifier: HSK3486-307
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multi-center, randomized, single-blind, propofol-controlled phase III clinical study. In this study, ICU patients undergoing mechanical ventilation are expected to be enrolled and will be randomly assigned to the HSK3486 group and the propofol group.

Conditions

Sedation in Intensive Care

Outcome Measures

Primary Outcomes (1)

• Success rate of sedation

  1\) The time period during which the RASS is in the range of +1 to -2 accounts for ≥ 70% of the total duration of study administration and 2) Remedial treatment is not used.

  Within 24 hours of administration

Secondary Outcomes (6)

• Mean qualified rate of sedation

  Within 24 hours of administration

• Use of study drug

  Within 24 hours of administration

• Dose of remedial drugs per unit weight

  Within 24 hours of administration

• Time to extubation

  Within 24 hours after administration

• Time to recovery

  Within 24 hours after administration

Study Arms (2)

HSK3486

EXPERIMENTAL

HSK3486 for Sedation

Drug: HSK3486

Propofol

ACTIVE COMPARATOR

Propofol for Sedation

Drug: Propofol

Interventions

HSK3486 DRUG

Loading Dose：0.1 mg/kg, infused with 4 min ± 30 s； 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. Range of maintenance dose: 0.06-0.8 mg/kg/h

HSK3486

Propofol DRUG

Loading Dose：0.5 mg/kg, infused with 4 min ± 30 s Maintenance Dose：Maintenance is started at 1.5 mg/kg/h, and the dose can be adjusted up and down by 0.25-0.5 mg/kg/h. Range of maintenance dose: 0.3-4 mg/kg/h

Propofol

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who require tracheal intubation for mechanical ventilation are expected to require 6-24 h of sedation after randomization;
• The target RASS for the required sedation of patients ranges from +1 to -2 points;
• Aged ≥ 18 and \< 80 years old, with no gender requirement;
• kg/m2 ≤ BMI ≤ 30 kg/m2;
• 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.

You may not qualify if:

• Patients known to be allergic to eggs, soy products, opioids and their antidotes, and propofol; patient having contraindications to propofol, opioids and their antidotes;
• Patients who have received sedation for more than 3 days in the ICU or in the general ward before being transferred to the ICU before signing informed consent form;
• Patients having the following medical history or evidence of any of the following at screening, which may increase sedation/anesthesia risk:
• 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; patients who require vasoactive drugs to maintain a normal blood pressure;
• Patients with mental system disorders (such as schizophrenia, depression, etc.) and cognitive disorders; patients with a history of abuse of psychotropic drugs and anesthetics; patients with a history of alcohol abuse within 3 months prior to screening; patients with a history of drug abuse; patients with a history of long-term use of psychotropic drugs, etc.;
• Severe hepatic and renal insufficiency (liver function: refer to child-pugh grade C, the scale is shown in Appendix 6; 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;
• Grand mal epilepsy and convulsion; craniocerebral injury, intracranial hypertension, cerebral aneurysm; a Glasgow coma scale (GCS) of ≤ 12 points (see Appendix 4 for the scale); a SOFA scale of \> 9 points (see Appendix 5 for the scale); patients with high paraplegia and general paralysis;
• Expected survival of ≤ 72 h.
• Pregnant or lactating females; women or men of child-bearing potential who are unwilling to use contraception through the study; subjects who are planning pregnancy within 1 month after the study (including male subjects);
• Have participated in any other clinical trials within 1 month prior to screening;
• Other conditions that patients are judged by the investigator to be unsuitable for participating in the study.

Sponsors & Collaborators

• Haisco Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, China

Location

Related Publications (3)

• Liu Y, Zuo L, Li X, Nie Y, Chen C, Liu N, Chen M, Wu J, Guan X. Early sedation using ciprofol for intensive care unit patients requiring mechanical ventilation: a pooled post-hoc analysis of data from phase 2 and phase 3 trials. Ann Intensive Care. 2024 Oct 26;14(1):164. doi: 10.1186/s13613-024-01390-3.

  PMID: 39455495 DERIVED

• Liu Y, Peng Z, Liu S, Yu X, Zhu D, Zhang L, Wen J, An Y, Zhan L, Wang X, Kang Y, Pan A, Yan J, Zhang L, Liu F, Zeng J, Lin Q, Sun R, Yu J, Wang H, Yao L, Chen C, Liu N, Nie Y, Lyu J, Wu K, Wu J, Liu X, Guan X. Efficacy and Safety of Ciprofol Sedation in ICU Patients Undergoing Mechanical Ventilation: A Multicenter, Single-Blind, Randomized, Noninferiority Trial. Crit Care Med. 2023 Oct 1;51(10):1318-1327. doi: 10.1097/CCM.0000000000005920. Epub 2023 Jun 5.

  PMID: 37272947 DERIVED

• Liu Y, Chen C, Liu N, Tong L, Nie Y, Wu J, Liu X, Gao W, Tang L, Guan X. Efficacy and Safety of Ciprofol Sedation in ICU Patients with Mechanical Ventilation: A Clinical Trial Study Protocol. Adv Ther. 2021 Oct;38(10):5412-5423. doi: 10.1007/s12325-021-01877-6. Epub 2021 Aug 21.

  PMID: 34417990 DERIVED

MeSH Terms

Interventions

HSK3486; Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: November 6, 2020
• Study Start: December 8, 2020
• Primary Completion: June 2, 2021
• Study Completion: August 17, 2021
• Last Updated: May 27, 2022

Record last verified: 2022-05

Locations

CN (1)