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Effect of mini-dose esketamine-dexmedetomidine combination supplemented intravenous analgesia on postoperative sleep quality in elderly patients after total knee arthroplasty:a double-blind randomised trial

Effect of mini-dose esketamine-dexmedetomidine combination supplemented intravenous analgesia on postoperative sleep quality in elderly patients after total knee arthroplasty:a double-blind randomised trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085253
Enrollment
Unknown
Registered
2024-06-04
Start date
2024-06-06
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

Sleep quality decreases after total knee arthroplasty

Interventions

Experimental group:The test drug was added to the analgesia pump
Control group:Placebo was added to the analgesia pump

Sponsors

Weifang People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 89 Years

Inclusion criteria

Inclusion criteria: (1) age =65 years old and <90 years old; (2) American Society of Anesthesiologists (ASA) grade I-III; (3) elective total knee arthroplasty under general anesthesia; (4) The operation was completed before 19:00; (5) Agree to participate in this study, agree to use intravenous analgesia pump, and sign the informed consent.

Exclusion criteria

Exclusion criteria: (1) emergency surgery; (2) patients with high risk of obstructive sleep apnea (STOP-Bang questionnaire score of 3 or above) or diagnosed patients; (3) severe cardiac dysfunction (preoperative LVEF<30% or NYHA class IV); (4) severe liver dysfunction (Child-Pugh grade C); (5) severe renal dysfunction (dialysis before operation); (6) expected to be transferred to intensive care unit after surgery; (7) allergy to any component of ketamine/esketamine/dexmedetomidine; (8) had received ketamine/esketamine/dexmedetomidine treatment; (9) sleep disorders requiring medical intervention (e.g., hypnotics) within the past month; (10) patients with sick sinus syndrome, severe sinus bradycardia (heart rate <50 beats/min) and atrioventricular block above degree II before surgery without pacemaker implantation; (11) Unable to communicate and cooperate with the study due to severe dementia or language disorder before surgery. (12) preoperative schizophrenia, epilepsy, Parkinson's disease and myasthenia gravis;

Design outcomes

Primary

MeasureTime frame
Sleep quality on the night of surgery;

Secondary

MeasureTime frame
RCSQ score on the first and second postoperative nights;The use of intravenous analgesia pump, other analgesic drugs and NRS pain score were followed up 0.5 and RASS;PONV in 24 and 48 hours after surgery;Postoperative Cognitive function;Score of sleep;

Countries

China

Contacts

Public ContactXiaoyan Wang

Weifang People's Hospital

wxyabc1990@163.com+86 176 6750 2101

Outcome results

None listed

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