Application research of fospropofol disodium in the treatment of refractory insomnia

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400094950

Enrollment

Unknown

Registered

2024-12-30

Start date

2025-02-01

Completion date

Unknown

Last updated

2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

insomnia

Interventions

Daytime text group:Daytime use of fospropofol disodium for sleep induction

Daytime control group:Daytime use of propofol disodium for sleep induction

Nighttime text group:Nighttime use of fospropofol disodium for sleep induction

Nighttime control group:Nighttime use of dexmedetomidine for sleep induction

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Voluntarily participate in this clinical trial and be able to independently complete relevant scale evaluations. (2) Age range is 18 to 65 years old. (3) The history of insomnia is more than 6 months, and after comprehensive treatment with two or more different types of medication, psychological therapy, physical therapy, stellate ganglion block, and oxygen autologous blood transfusion, insomnia symptoms still exist. (4) The Insomnia Severity Index (ISI) score is greater than 14. (5) Pittsburgh Sleep Quality Index (PSQI) score>7 points. (6) The American Society of Anesthesiologists (ASA) grades I-II.

Exclusion criteria

Exclusion criteria: (1) Patients with a history of severe head trauma, epilepsy, schizophrenia, senile dementia, cerebrovascular disease, and severe cognitive impairment. (2) Patients with severe hypertension, arrhythmia, and cardiopulmonary dysfunction. (3) Patients who are expected to have difficult airways or severe sleep apnea syndrome. (4) Patients with hyperthyroidism or diabetes without regular treatment. (5) There is cognitive impairment and inability to understand the content of insomnia related scales. (6) Individuals with a history of mental illness or currently receiving psychiatric medication treatment. (7) Pregnancy, lactation, and short-term pregnancy planning. (8) Allergic to disodium propofol, propofol, or related components of the two drugs mentioned above.

Design outcomes

Primary

Measure	Time frame
Sleep related scales;	—

Secondary

Measure	Time frame
Vital signs;Complications;Stress hormone level;	—

Countries

China

Contacts

Public ContactLiu Minqiang

Shenzhen Third People's Hospital

liumq06@sina.com+86 182 0098 1571

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026