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 site in 1 country30 target enrollmentDecember 1, 2021

ConditionsChronic Insomnia

Interventionsciprofol medium/long chain fat emulsion injection (C8-24Ve)

Drugsciprofol medium/long chain fat emulsion injection (C8-24Ve)

Overview

Phase: Not Applicable
Intervention: ciprofol
Conditions: Chronic Insomnia
Sponsor: Sichuan Provincial People's Hospital
Enrollment: 30
Locations: 1
Primary Endpoint: Polysomnography (PSG)
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 1, 2021

End Date

June 1, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sichuan Provincial People's Hospital

Responsible Party

Principal Investigator

Mengchang Yang

Deputy Chief Physician

Sichuan Provincial People's Hospital

Eligibility Criteria

Inclusion Criteria

•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.

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;
•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;