Study for Evaluating the Efficacy of Ciprofol in Patients Under Narcotic Sleep With Chronic Insomnia
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Ciprofol
|
Drug: ciprofol
intravenous infusion of ciprofol at 0.12 mg/kg, followed by 0.4-1.6 mg/kg/h for maintenance
|
| Placebo Comparator: placebo
|
Drug: medium/long chain fat emulsion injection (C8-24Ve)
at the infusion rate of 25-30 mL/h
|
Outcome Measures
Primary Outcome Measures
- Polysomnography (PSG) [Day -2 to Day 90]
total sleep time (TST)
- Polysomnography (PSG) [Day -2 to Day 90]
sleep latency (SL)
- Polysomnography (PSG) [Day -2 to Day 90]
wake after sleep onset (WASO)
- Sleep log [Day -2 to Day 90]
subjective total sleep time (sTST)
- Sleep log [Day -2 to Day 90]
subjective sleep-onset latency (sSOL)
- Sleep log [Day -2 to Day 90]
subjective wake after sleep onset (sWASO)
Secondary Outcome Measures
- Self-rating scales [Day -2 to Day 90]
Pittsburgh Sleep Quality Index (PSQI)（0-21）
- Self-rating scales [Day -2 to Day 90]
Insomnia Severity Index (ISI)（0-28）
- Self-rating scales [Day -2 to Day 90]
PHQ-9 Depression Test Questionnaire（0-27）
- Self-rating scales [Day -2 to Day 90]
GAD-7 Anxiety Test Questionnaire（0-21）
- Self-rating scales [Day -2 to Day 90]
Epworth Somnolence Scale（0-24）;
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male or female aged 18 (inclusive) to 70 (inclusive) years old;
-
ASA class of I-II;
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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:
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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;
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At least one of the following daytime symptoms: tiredness, short tempered, work/study/social skills decreased;
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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.
Exclusion Criteria:
-
With contraindications to deep sedation/general anesthesia or a history of past sedation/anesthesia accidents;
-
With a history of allergy or contraindications to anesthetics;
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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;
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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);
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History of gastrointestinal disorders: gastrointestinal retention, active hemorrhage, or conditions that may lead to reflux and aspiration;
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History of blood donation or blood loss of ≥ 400 mL within 3 months before screening;
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With the following airway management risks at screening:
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History of asthma or stridor;
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Sleep apnea syndrome;
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History or family history of malignant hyperthermia;
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History of tracheal intubation failure;
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Judged by investigators to have difficult airway or judged as difficult tracheal intubation (modified Mallampati class IV) at screening;
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Receipt of any of the following medications/therapies at screening/baseline:
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Any clinical study within 1 month before screening;
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Sedatives/anesthetics, and/or sedative-hypnotics within 72 h before baseline;
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Antidepressants and anxiolytics within 14 days before baseline;
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Laboratory test abnormalities at screening:
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Total bilirubin > 2 × ULN (upper limit of normal);
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Aspartate aminotransferase (AST) and alanine transaminase (ALT) > 2 × ULN;
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Blood creatinine > 1.5 × ULN;
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Unable to fast for 6 h before dose administration;
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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);
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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);
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Unable to avoid engaging in dangerous occupations requiring concentration and/or motor coordination 72 h after administration;
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Judged by investigators to be unsuitable for participating in this trial for any reason.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sichuan Provincial People's Hospital | Sichuan | China |
Sponsors and Collaborators
- Sichuan Provincial People's Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HSK3486-IIT-01