NCT04958382进行中（未招募）不适用
A Single Center, Randomized, Single Blind, Exploratory Study for Evaluating the Efficacy of Ciprofol in Patients Under Narcotic Sleep With Chronic Insomnia
Sichuan Provincial People's Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年12月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Polysomnography (PSG)
研究概览
简要总结
This is a single center, randomized, single blind, exploratory clinical study.About 30 patients with chronic insomnia are planned to be enrolled in this study and randomized into two groups by a ratio of 4:1 (Figure 1), with group 1 (24 subjects) for ciprofol and group 2 (6 subjects) for placebo (fat emulsion). Cognitive behavioral therapy (CBT) will be given to these patients during the treatment.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 18 (inclusive) to 70 (inclusive) years old;
- •ASA class of I-II;
- •With chronic insomnia refractory to conventional drugs in the past 3 months (benzodiazepine receptor agonists and other drugs). Other drugs: melatonin, melatonin receptor agonists, and traditional Chinese medicine;
- •Compliant with the diagnostic criteria of ICSD-3 chronic insomnia:
- •At least one of the following chief complaints: initial insomnia, difficulty in sleep maintenance, early awakening, refusal to go to bed at an appropriate time, and difficulty in falling asleep without nursing;
- •At least one of the following daytime symptoms: tiredness, short tempered, work/study/social skills decreased;
- •Occurrence of the above symptoms at least 3 times per week and lasting for more than 3 months;
- •Voluntarily adopt narcotic sleep and obtain the written informed consent form.
排除标准
- •With contraindications to deep sedation/general anesthesia or a history of past sedation/anesthesia accidents;
- •With a history of allergy or contraindications to anesthetics;
- •With a medical history or evidence of any of the followings before screening/at baseline, which may increase sedation/anesthesia risks:
- •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 despite antihypertensive treatment], 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);
- •History of respiratory system disorders: respiratory insufficiency, history of obstructive pulmonary disease, history of bronchospasm requiring treatment within 3 months before screening, and acute respiratory tract infection with obvious symptoms such as fever, wheezing, nasal obstruction, and cough within 1 week before baseline;
- •History of neurological and psychiatric disorders: craniocerebral injury, possible convulsions, myoclonus, intracranial hypertension, cerebral aneurysms, history of cerebrovascular accidents; schizophrenia, mania, insanity, history of cognitive disorder; history of epilepsy; mental disorder suggested by Mini International Neuropsychiatric Interview (MINI);
- •History of gastrointestinal disorders: gastrointestinal retention, active hemorrhage, or conditions that may lead to reflux and aspiration;
- •History of blood donation or blood loss of ≥ 400 mL within 3 months before screening;
- •With the following airway management risks at screening:
- •History of asthma or stridor;
- •Sleep apnea syndrome;
- •History or family history of malignant hyperthermia;
- •History of tracheal intubation failure;
- •Judged by investigators to have difficult airway or judged as difficult tracheal intubation (modified Mallampati class IV) at screening;
- •Receipt of any of the following medications/therapies at screening/baseline:
- •Any clinical study within 1 month before screening;
- •Sedatives/anesthetics, and/or sedative-hypnotics within 72 h before baseline;
- •Antidepressants and anxiolytics within 14 days before baseline;
- •Laboratory test abnormalities at screening:
- •Total bilirubin > 2 × ULN (upper limit of normal);
- •Aspartate aminotransferase (AST) and alanine transaminase (ALT) > 2 × ULN;
- •Blood creatinine > 1.5 × ULN;
- •Unable to fast for 6 h before dose administration;
- •With a history of smoking, drug abuse and/or positive urine drug screening results, or positive breath alcohol test results at baseline and/or a history of alcohol abuse within 3 months before screening. Alcohol abuse is defined as an average of > 2 units of alcohol consumed per day (1 unit = 360 mL of beer with 5% alcohol, 45 mL of liquor with 40% alcohol, or 150 mL of wine);
- •Pregnant or breastfeeding females; women of child-bearing potential or men who are unwilling to use contraception during the trial; or patients who are planning pregnancy within 1 month after the trial (including male patients);
- •Unable to avoid engaging in dangerous occupations requiring concentration and/or motor coordination 72 h after administration;
- •Judged by investigators to be unsuitable for participating in this trial for any reason.
研究组 & 干预措施
Ciprofol
Experimental
干预措施: ciprofol (Drug)
placebo
Placebo Comparator
干预措施: medium/long chain fat emulsion injection (C8-24Ve) (Drug)
结局指标
主要结局
Polysomnography (PSG)
时间窗: Day -2 to Day 90
wake after sleep onset (WASO)
Sleep log
时间窗: Day -2 to Day 90
subjective wake after sleep onset (sWASO)
次要结局
- Self-rating scales(Day -2 to Day 90)
研究者
Mengchang Yang
Deputy Chief Physician
Sichuan Provincial People's Hospital
研究点 (1)
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