NCT04111159已完成3 期
A Multi-Center, Randomized, Double-Blind, Propofol-Controlled Phase III Clinical Trial Evaluating the Efficacy and Safety of HSK3486 Injectable Emulsion for the Induction of Sedation/Anesthesia in Subjects Undergoing Fiberoptic Bronchoscopy
Sichuan Haisco Pharmaceutical Group Co., Ltd1 个研究点 分布在 1 个国家目标入组 267 人开始时间: 2019年12月6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
- 267
- 试验地点
- 1
- 主要终点
- Success rate of fiberoptic bronchoscopy. A successful diagnosis/treatment should meet both of the following:
研究概览
简要总结
This is a Multi-Center, Randomized, Double-Blind, Propofol-Controlled Phase III Clinical Trial. Around 260 eligible subjects are planned to be enrolled and randomized in a 1:1 ratio to either the HSK3486 arm or propofol arm. The main objective is to evaluate the efficacy of HSK3486 vs. propofol for the induction of sedation/anesthesia in subjects undergoing fiberoptic bronchoscopy.
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
- Double (Participant, Investigator)
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
- •1.Subjects receiving laryngeal mask airway-assisted diagnostic and/or therapeutic fiberoptic bronchoscopy; 2.Male or female, ASA I-III, ≥ 18 and < 80 years old; 3.Body mass index (BMI) ≥ 18 and ≤ 30 kg/m2; 4.Respiratory rate ≥ 10 and ≤ 24 bpm; SpO2 ≥ 93%; SBP ≥ 90 mmHg; DBP ≥ 55 mmHg; HR ≥ 50 and ≤ 100 bpm during screening and baseline periods; 5.Capable of understanding the procedure and method of this study, willing to sign an informed consent form and to complete this study in strict accordance with the study protocol.
排除标准
- •Patients with contraindications to deep sedation/general anesthesia or a history of past sedation/anesthesia accidents;
- •Patient 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 undergone endotracheal intubation and/or mechanical ventilation prior to diagnostic or therapeutic bronchoscopy;
- •Medical history or evidence of any of the following prior to screening/at baseline, which may increase sedation/anesthesia risk:
- •History of cardiovascular diseases: uncontrolled hypertension [systolic blood pressure (SBP) ≥170 mmHg and/or diastolic blood pressure (DBP) ≥105 mmHg without treatment, or SBP > 160 mmHg and/or DBP >100 mmHg after antihypertensive treatment], aneurysm, severe arrhythmia, heart failure, Adams-stokes syndrome, New York Heart Association (NYHA) Class ≥ III, severe superior vena cava syndrome, pericardial effusion, acute myocardial ischemia, unstable angina, myocardial infarction within 6 months before screening, history of tachycardia/bradycardia requiring medical treatment, II-III degree atrioventricular block (excluding patients with pacemakers) or QTcF interval ≥ 450 ms [during screening only (corrected using Fredericia's formula1)];
- •History of respiratory diseases: severe chronic obstructive pulmonary disease, acute exacerbation of chronic obstructive pulmonary disease, severe airway stenosis, throat mass, history of tracheoesophageal fistula or airway tear, severe respiratory infection within 2 weeks prior to screening;
- •History of neurological and psychiatric disorders: craniocerebral injury, possible convulsions, intracranial hypertension, cerebral aneurysms, history of cerebrovascular accidents; schizophrenia, mania, insanity, long-term use of psychotropic drugs, and history of cognitive dysfunction;
- •History of gastrointestinal diseases: gastrointestinal retention, active hemorrhage, or history of gastroesophageal reflux or obstruction that may lead to aspiration;
- •History of uncontrolled clinically significant liver, kidney, blood system, nervous system or metabolic system diseases judged by the investigator to be probably unsuitable for involvement in the study;
- •History of alcohol abuse within 3 months prior to screening, abuse defined as average of > 2 units of alcohol per day (1 unit = 360 mL beer or 45 mL liquor with 40% alcohol or 150 mL wine);
- •History of drug abuse within 3 months prior to screening;
- •History of blood transfusion within 14 days prior to screening;
- •Patients with the following respiratory risks during screening/at baseline:
- •Acute asthma attack;
- •Sleep apnea syndrome;
- •History of malignant hyperthermia or family history;
- •History of failed tracheal intubation;
- •Difficult airway (modified Mallampati score ≥ III) as determined by the investigator;
- •Patient who received any of the following medications or treatments during screening/at baseline:
- •Received any investigational drug within 1 month prior to screening;
- •Received propofol, other sedatives/anesthetics, and/or opioid analgesics or compounds containing analgesics within 72 h prior to baseline;
- •Laboratory results meeting any of the following criteria during screening/at baseline, confirmed by re-examination:
- •WBC ≤ 3.0 × 10^9/L;
- •Platelets ≤ 80 × 10^9/L;
- •Hemoglobin ≤ 80 g/L;
- •Prothrombin time ≥ 1.5 × ULN;
- •Activated partial thromboplastin time (aPTT) ≥ 1.5 × ULN;
- •ALT and/or AST ≥ 3 × ULN;
- •Total bilirubin ≥ 1.5 × ULN;
- •Serum creatinine ≥ 1.5 × ULN.
- •Women who are pregnant or breastfeeding; women of child-bearing potential or men who are unwilling to use contraception during the trial; or subjects who are planning pregnancy within 3 month after the completion of the trial (including male subjects);
- •Subject judged by the investigator to have any other factors unsuitable for involvement in the study.
研究组 & 干预措施
HSK3486
Experimental
Subjects < 65 years old:0.4mg/kg/0.15mg/kg;Subjects ≥ 65 years old:75% of the dose for subjects < 65 years old.
干预措施: HSK3486 (Drug)
Propofol
Active Comparator
Subjects < 65 years old:2mg/kg/0.75mg/kg;Subjects≥ 65 years old:75% of the dose for subjects < 65 years old.
干预措施: Propofol (Drug)
结局指标
主要结局
Success rate of fiberoptic bronchoscopy. A successful diagnosis/treatment should meet both of the following:
时间窗: During induction of sedation/anesthetic on day 1
1. Completion of fiberoptic bronchoscopy; 2. No alternative sedation/anesthetic drugs are used, that is, the number of doses of the study drug is ≤ 5 times within any given 15-minute period, starting from the initial administration until the fiberoptic bronchoscopy is completed.
次要结局
- Time to successful sedation/anesthetic induction(From the initial administration of the investigational drug to the first time when MOAA/S is ≤1 on day 1)
- Time to fully awake(From the last dose of study drug or rescue sedative AND from end of fiberoptic bronchoscopy until the patient has recovered to fully alert on day 1)
- Time to discharge(Time from the last dose of study drug or rescue sedative and from the end of fiberoptic bronchoscopy until discharge (defined as the ability to walk unassisted) on day 1)
- Use of questionnaires to estimate sedation/anesthesia satisfaction, including satisfaction assessments of the subject and anesthesiologist(During induction of sedation/anesthetic on day 1)
- Use of the investigational drug and alternative drugs(During induction of sedation/anesthetic on day 1)
研究者
研究点 (1)
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