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Effects of intravenous anaesthetics on the sleep quality and sleep structure in healthy volunteers: a randomized, single-blind, crossover, controlled study

Effects of intravenous anaesthetics on the sleep quality and sleep structure in healthy volunteers: a randomized, single-blind, crossover, controlled study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200060167
Enrollment
Unknown
Registered
2022-05-21
Start date
2021-02-21
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

sleep disorders

Interventions

Group A:Stage one propofol, stage two Remazolam toluenesulfate for injection
Group B:Stage one, Remazolam toluenesulfate, stage two, propofol

Sponsors

Zhongnan Hospital of Wuhan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. The subject's written informed consent has been obtained before conducting any examination, sampling, or analysis related to the study; 2. Aged 18~40 years; 3. ASA grading ?-?.

Exclusion criteria

Exclusion criteria: 1. Patients with sleep disorders; 2. Habitual short sleepers; 3. Patients with chronic pain disease and long-term use of sedative and analgesic drugs; 4. Patients who took sedative and analgesic drugs 24h before surgery; 5. Drug abusers, drug and alcohol addicts; 6. Patients with mental disorders, depression, dementia, neurological diseases, previous history of brain injury, craniotomy, or combined with cerebral aneurysm, cerebrovascular malformation, respiratory diseases, cardiovascular system diseases; 7. Previously known hepatic and renal insufficiency; 8. Patients with language disorders, vision and hearing disorders, unable to communicate with others, unable to take care of themselves, and unable to record sleep independently, such as patients with Alzheimer's disease; 9. Pregnancy; 10. Systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg; Heart rate > 100bpm or 30; 12. Neck circumference > 40cm; 13. Night shift workers.

Design outcomes

Primary

MeasureTime frame
Sleep structure;

Secondary

MeasureTime frame
Total sleep time;Sleep efficiancy;Number of awakening;N2 proportion;N3 proportion;Pittsburgh sleep quality index;Urine levels of 6-hydroxymelatonin;Bispectral index;

Countries

China

Contacts

Public ContactChen Ting

Zhongnan Hospital of Wuhan University

chent901120@126.com+86 13554439990

Outcome results

None listed

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