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Effect of intraoperative goal-directed sedation with Ramazolam toluene sulfonate on postoperative sleep quality of elderly patients undergoing arthroplasty: a multicenter randomized controlled trial

Effect of intraoperative goal-directed sedation with Ramazolam toluene sulfonate on postoperative sleep quality of elderly patients undergoing arthroplasty: a multicenter randomized controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000041286
Enrollment
Unknown
Registered
2020-12-23
Start date
2021-01-01
Completion date
Unknown
Last updated
2021-03-08

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

Conditions

Sleep disorder

Interventions

experimental group:Goal-directed sedation with Ramazolam

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1.Aged >= 65 years; 2.Scheduled to undergo total hip replacement, femoral head replacement or total knee arthroplasty under intravertebral anesthesia; 3.Agreement of participating in the study and informed consent being signed.

Exclusion criteria

Exclusion criteria: 1.Being allergic to benzodiazepines or dexmedetomidine; 2.Requring for hypnotic every night within one month before surgery; 3.Serious hepatic dysfunction (in Child-Pugh grade C level); 4.Serious renal dysfunction (requiring for dialysis); 5.Known sick sinus syndrome, severe sinus bradycardia ( < 50 beats per min [bpm]), or second degree or more severe atrioventricular block without pacemaker; 6.Hypotension (SBP < 90 mmHg, MAP < 70 mmHg or SBP is more than 30% lower than base value) or anticipated survival time < 24 h; 7.ASA grade of IV and above; 8.Other conditions that researchers consider it inappropriate to be included in the study.

Design outcomes

Primary

MeasureTime frame
Sleep quality of postoperative night;

Secondary

MeasureTime frame
Sleep quality of postoperative night and 1-2 days after surgery;Pain score of 1-3 days after surgery;nausea and vomiting of 1-3 days after surgery;The length of hospitalization after surgery;Complications and survival within 30 days after operation;

Countries

China

Contacts

Public ContactMeng Zhaoting

Peking University First Hospital

526589053@qq.com+86 15652302036

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 9, 2026