NCT04620031已完成3 期
A Multi-Center, Randomized, Single-Blind, Propofol-Controlled Phase III Clinical Study Evaluating Sedation of Intravenous Administration of HSK3486 Injectable Emulsion in ICU Patients Undergoing Mechanical Ventilation
Haisco Pharmaceutical Group Co., Ltd.1 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2020年12月8日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Success rate of sedation
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
- •18 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.
排除标准
- •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.
研究组 & 干预措施
HSK3486
Experimental
HSK3486 for Sedation
干预措施: HSK3486 (Drug)
Propofol
Active Comparator
Propofol for Sedation
干预措施: Propofol (Drug)
结局指标
主要结局
Success rate of sedation
时间窗: Within 24 hours of administration
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.
次要结局
- 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)
- Incidence of adverse events(From day -1 to 24 hours after administration)
- Time to recovery(Within 24 hours after administration)
研究者
研究点 (1)
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