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Effects of Remimazolam Tosilate on Postoperative Sleep Disturbances and Recovery Quality in Elderly Obese Patients Undergoing Total Knee Arthroplasty

Effects of Remimazolam Tosilate on Postoperative Sleep Disturbances and Recovery Quality in Elderly Obese Patients Undergoing Total Knee Arthroplasty

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109438
Enrollment
Unknown
Registered
2025-09-18
Start date
2025-09-22
Completion date
Unknown
Last updated
2025-09-22

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

Conditions

sleep disorders

Interventions

Remimazolam group:Remimazolam induction and maintenance

Sponsors

The First Affiliated Hospital of the University of Science and Technology of China(Anhui Provincial Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 90 Years

Inclusion criteria

Inclusion criteria: (1) patients undergoing elective total knee arthroplasty; (2) age >=65 years old; (3) ASA physical status I~III; (4) BMI=30 kg/m2 or waist-to-hip ratio (WHR) > 0.9 in men or > 0.85 in women.

Exclusion criteria

Exclusion criteria: (1) Severe cardiac arrhythmias, including sick sinus syndrome, symptomatic bradycardia (heart rate below 50 beats per minute), or second- or third-degree atrioventricular block without pacemaker implantation; (2) Severe renal insufficiency (requiring renal replacement therapy); (3) Child-Pugh C grade; (4) ASA physical status >= IV grade; (5) Allergy to the study drug; (6) Patients with known chronic sleep disorders and those who are on long-term benzodiazepine therapy; (7) Patients with preoperative psychiatric disorders or cognitive dysfunction and who are unable to cooperate with the scoring; (8)Other circumstances deemed ineligible for study participation by investigators.

Design outcomes

Primary

MeasureTime frame
Quality of sleep;

Secondary

MeasureTime frame
Anxiety score;The incidence of postoperative delirium;Postoperative recovery quality score;Pain score;Plasma concentrations of inflammatory cytokines/factors;

Countries

China

Contacts

Public ContactWang Sheng

The First Affiliated Hospital of the University of Science and Technology of China(Anhui Provincial Hospital)

iamsheng2020@ustc.edu.cn+86 191 5600 7726

Outcome results

None listed

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