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The Effect of improving sleep quality during dexmedetomidine and ramazolam on sleep disorders in elderly patients after knee replacement surgery

The Effect of improving sleep quality during dexmedetomidine and ramazolam on sleep disorders in elderly patients after knee replacement surgery

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096906
Enrollment
Unknown
Registered
2025-02-08
Start date
2025-02-12
Completion date
Unknown
Last updated
2025-02-17

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

Conditions

osteoarthritis

Interventions

Dex group:After spinal anesthesia, dexmedetomidine was pumped to assist sedation during operation.
Rem group:After spinal anesthesia, Remazolam was pumped to assist sedation during operation.

Sponsors

The First Affiliated Hospital of Shihezi University Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 90 Years

Inclusion criteria

Inclusion criteria: (1) Age over 65, regardless of sex; (2)ASAI-II, with no history of major systemic diseases; (3) preoperative PSQI score > 6 (sleep disorder); (4) Patients who intend to undergo joint replacement under spinal anesthesia; (5) Be able to cooperate with the perioperative sleep quality assessment and sign the informed consent.

Exclusion criteria

Exclusion criteria: (1) allergic to local anesthetics and dexmedetomidine and rimazolam; (2) People with communication disorder and mental disorder; (3) Severe arrhythmia (pacemaker, sick sinus syndrome, severe bradycardia (< 50 beats/min) or more than second degree atrioventricular block); (4) recent use of antipsychotics, alcoholism or drug abuse; Complicated with serious cardiovascular, liver and kidney diseases and cerebrovascular accidents.

Design outcomes

Primary

MeasureTime frame
RCSQ score on the first night after operation;

Secondary

MeasureTime frame
Recovery Quality 15 Item Scale;Visual Analogue Scale, VAS;Occurrence of adverse reactions;Hemodynamic indexes;Intraoperative sleep monitoring band data;Intraoperative BIS value;

Countries

China

Contacts

Public ContactHehaichuan

The First Affiliated Hospital of Shihezi University Medical College

2297569047@qq.com+86 177 2194 8953

Outcome results

None listed

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