Trials / Unknown
UnknownNCT04958382
Study for Evaluating the Efficacy of Ciprofol in Patients Under Narcotic Sleep With Chronic Insomnia
A Single Center, Randomized, Single Blind, Exploratory Study for Evaluating the Efficacy of Ciprofol in Patients Under Narcotic Sleep With Chronic Insomnia
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Sichuan Provincial People's Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ciprofol | intravenous infusion of ciprofol at 0.12 mg/kg, followed by 0.4-1.6 mg/kg/h for maintenance |
| DRUG | medium/long chain fat emulsion injection (C8-24Ve) | at the infusion rate of 25-30 mL/h |
Timeline
- Start date
- 2021-12-01
- Primary completion
- 2023-12-31
- Completion
- 2024-06-01
- First posted
- 2021-07-12
- Last updated
- 2023-11-30
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04958382. Inclusion in this directory is not an endorsement.