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Clinical observation of remazolam in the treatment of postoperative sleep disorders

Clinical observation of remazolam in the treatment of postoperative sleep disorders

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049632
Enrollment
Unknown
Registered
2021-08-07
Start date
2021-08-05
Completion date
Unknown
Last updated
2022-04-19

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

Conditions

postoperative sleep disturbance

Interventions

Group 1:None
Group 2:Remazolam 0.5mg/kg nasal spray
Group 3:Remazolam 0.75mg/kg nasal spray
Group 4:Remazolam 0.2mg/kg/h pump injection
Group 5:Remazolam 0.4mg/kg/h infusion

Sponsors

Plastic Surgery Hospital of Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Patients undergoing maxillofacial surgery under general anesthesia and endotracheal intubation, no gender restrictions, aged 18-40 years, ASA I or II. 2. Stay in the anesthesia recovery room on the first night after surgery.

Exclusion criteria

Exclusion criteria: 1. Have other system diseases, such as congenital heart disease, hypertension, history of epilepsy. 2. Patients with severe sleep apnea syndrome, depression, use of sleep aids and sedative and analgesic drugs, foreign bodies in the respiratory tract, tumors, polyps, abscesses, and upper respiratory tract infections in the past 2 weeks. 3. Patients with hearing and speech impairment who cannot cooperate and refuse to join the group.

Design outcomes

Primary

MeasureTime frame
sleep rhythm;

Secondary

MeasureTime frame
PSQI;Total length of hospitalization and total cost;Medication complications;

Countries

China

Contacts

Public ContactWang Ye

Chinese Academy of Medical Sciences Peking Union Medical College Plastic Surgery Hospital

wangyedeemail@126.com+86 15801597504

Outcome results

None listed

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