NCT04147416已完成2 期
A Multi-center, Open-label, Randomized, Propofol-controlled Study Evaluating the Efficacy and Safety of Intravenous Administration of HSK3486 Injectable Emulsion for Sedation in Intensive Care (ICU) Patients Undergoing Mechanical Ventilation
Sichuan Haisco Pharmaceutical Group Co., Ltd1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2019年11月22日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Mean time to sedation
研究概览
简要总结
This is a multi-center, open-label, randomized, propofol-controlled phase II clinical trial.A total of ICU patients undergoing mechanical ventilation are intended to be enrolled and randomly assigned to HSK3486 group and propofol group in a 2:1 ratio.
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
- None
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 need tracheal intubation for mechanical ventilation and need 6-24 h of sedation after randomization, as anticipated;
- •The target RASS score is between +1 and -2;
- •18 ≤ age < 80 years old; with no restriction on gender;
- •18 kg/m2 ≤ BMI ≤ 30 kg/m2;
- •The patients or their family members well understand the purpose and significance of the trial, voluntarily participate in this clinical trial, 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; patients having contraindications to propofol, opioids and their antidotes;
- •Patients having the following medical history or evidence at screening, which may increase sedation/anesthesia risk:
- •Cardiovascular system: Class III and IV heart failure by New York Heart Association (NYHA), Adams-Stokes syndrome; acute coronary syndrome (ACS) within 6 months prior to screening; bradycardia requiring medications and/or heart rate ≤ 50 beats/min; serious arrhythmia history such as Degree II-III atrioventricular block (excluding patients with pacemakers); acute and chronic myocarditis; systolic pressure ≤ 90 mmHg even when large dose of vasoactive drug (such as norepinephrine ≥ 0.6 μg/kg/min) is used;
- •Patients with mental disorders (such as schizophrenia, depression, etc.) and cognitive impairment; past abuse history of psychotropics and anesthetics, and long-term use of psychotropics;
- •Patients with moderate to severe hepatic and renal dysfunctions (liver function: Child-Pugh Grade B and C, scale in Annex 9; renal function: glomerular filtration rate eGFR ≤ 60 mL/(min•1.73 m2) [eGFR is calculated with the Modification of Diet in Renal Disease (MDRD) formula: eGFR = 186 × serum creatinine (SCr)-1.154 × age-0.203 × 0.742 (female)]; patients under dialysis;
- •Epileptic seizures, convulsions; craniocerebral injury, intracranial hypertension, cerebral aneurysms; Glasgow Coma Score (GCS) ≤ 12 (scale in Annex 6); SOFA > 9 (scale in Annex 7);
- •Expected survival ≤ 72 h;
- •Laboratory measures at screening period meet the following criteria:
- •Neutrophil count ≤ 1.0 × 10^9/L;
- •Platelet count ≤ 50 × 10^9/L;
- •Hemoglobin ≤ 70 g/L;
- •Pregnant or lactating females; fertile females or males reluctant to receive contraception through the study; any subject planning for pregnancy within 1 month after the study (including male subject);
- •Participated in other drug clinical trials within 1 month prior to screening; Other reasons rendering a subject unsuitable for participation in this study as per the judgment of the investigator.
研究组 & 干预措施
Propofol
Active Comparator
Propofol for Sedation
干预措施: Propofol 0.5-1.0/1.5 mg/kg group (Drug)
HSK3486
Experimental
HSK3486 for Sedation
干预措施: HSK3486 0.1-0.2 /0.3 mg / kg group (Drug)
结局指标
主要结局
Mean time to sedation
时间窗: at day 1
Defined as the mean time during which the hourly RASS is in the range of +1- -2 during the study treatment
次要结局
- Unit weight dose of remifentanil(at day 1)
- Recovery time(at day 1)
- Minimum maintenance dose(at day 1)
- Extubation time(at day 1)
- Study drug use(at day 1)
- Unit weight dose of remedial drug(at day 1)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
A Clinical Trial Evaluating the Efficacy and Safety of HSK3486 Injectable Emulsion in Elective Surgery PatientsInduction and Maintenance of General AnesthesiaNCT04048811Sichuan Haisco Pharmaceutical Group Co., Ltd46
已完成
2 期
A Clinical Study Evaluating Sedation of Intravenous Administration of HSK3486 in ICU Patients Undergoing Long-Term Mechanical VentilationSedation in Intensive CareNCT04669821Haisco Pharmaceutical Group Co., Ltd.20
已完成
1 期
A Study Evaluating the Safety and Pharmacokinetics/Pharmacodynamics of HSK3486AnesthesiaSedationNCT03745625Sichuan Haisco Pharmaceutical Group Co., Ltd16
已完成
2 期
To Reduce the Use of Chemotherapy in Postmenopausal Patients With ER-positive and HER2-positive Breast Cancer (TOUCH)Estrogen Receptor Positive TumorHER2-positive Breast CancerBreast CancerNCT03644186ETOP IBCSG Partners Foundation147
已完成
2 期
Evaluation of Early Bactericidal Activity and Safety in Pulmonary Tuberculosis With WX-081Pulmonary TuberculosisNCT04608955Shanghai Jiatan Pharmatech Co., Ltd99