study for evaluating the efficacy of ciprofol in patients under narcotic sleep with chronic insomnia

Conditions: Chronic Insomnia

Summary: 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.


Eligibility criteria:
inclusion criteria: 1. male or female aged 18 (inclusive) to 70 (inclusive) years old; 2. asa class of i-ii; 3. 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; 4. compliant with the diagnostic criteria of icsd-3 chronic insomnia: 1. 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; 2. at least one of the following daytime symptoms: tiredness, short tempered, work/study/social skills decreased; 3. occurrence of the above symptoms at least 3 times per week and lasting for more than 3 months; 5. voluntarily adopt narcotic sleep and obtain the written informed consent form. exclusion criteria: 1. with contraindications to deep sedation/general anesthesia or a history of past sedation/anesthesia accidents; 2. with a history of allergy or contraindications to anesthetics; 3. with a medical history or evidence of any of the followings before screening/at baseline, which may increase sedation/anesthesia risks: 1. 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); 2. 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; 3. 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); 4. history of gastrointestinal disorders: gastrointestinal retention, active hemorrhage, or conditions that may lead to reflux and aspiration; 5. history of blood donation or blood loss of ≥ 400 ml within 3 months before screening; 4. with the following airway management risks at screening: 1. history of asthma or stridor; 2. sleep apnea syndrome; 3. history or family history of malignant hyperthermia; 4. history of tracheal intubation failure; 5. judged by investigators to have difficult airway or judged as difficult tracheal intubation (modified mallampati class iv) at screening; 5. receipt of any of the following medications/therapies at screening/baseline: 1. any clinical study within 1 month before screening; 2. sedatives/anesthetics, and/or sedative-hypnotics within 72 h before baseline; 3. antidepressants and anxiolytics within 14 days before baseline; 6. laboratory test abnormalities at screening: 1. total bilirubin \> 2 × uln (upper limit of normal); 2. aspartate aminotransferase (ast) and alanine transaminase (alt) \> 2 × uln; 3. blood creatinine \> 1.5 × uln; 7. unable to fast for 6 h before dose administration; 8. 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); 9. 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); 10. unable to avoid engaging in dangerous occupations requiring concentration and/or motor coordination 72 h after administration; 11. judged by investigators to be unsuitable for participating in this trial for any reason.