Actively Recruiting

Phase 4
Age: 65Years - 90Years
All Genders
ID05950646

Effect of Mini-dose Dexmedetomidine-Esketamine Infusion on Sleep Quality in Older Patients Undergoing Knee or Hip Replacement Surgery: A Multicenter Randomized Controlled Trial

Led by Peking University First Hospital · Updated on 2025-07-30

154

Participants Needed

2

Research Sites

4 weeks

Total Duration

On this page

Sponsors

P

Peking University First Hospital

Lead Sponsor

B

Beijing Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Older adults scheduled for knee or hip replacement surgery often experience sleep disturbances, which can lead to worse outcomes such as increased risk of delirium, cardiac events, and delayed recovery. This trial investigates whether a mini-dose combination infusion of dexmedetomidine and esketamine at night can improve perioperative sleep quality in these patients. Dexmedetomidine is known for its sedative and analgesic effects through natural sleep pathways, while low-dose esketamine has shown sleep-promoting and anti-depressive effects. Participants will be randomly assigned to receive either a continuous infusion of a dexmedetomidine-esketamine combination or a placebo (normal saline). The infusion starts at 8 pm the night before surgery and continues until 8 am on the third morning after surgery. Dexmedetomidine will be administered at 0.02 µg/kg/h and esketamine at 5 µg/kg/h in the experimental group, while the placebo group will receive saline at the same rate and timing. During the study, participants’ sleep quality will be assessed subjectively on the night of surgery and through various measures such as total sleep time, sleep efficiency, sleep onset latency, and wake after sleep onset from the night before surgery until several nights after surgery. The trial uses polysomnographic monitoring and questionnaires to evaluate sleep patterns and recovery. The study aims to improve postoperative recovery by enhancing sleep quality and will monitor safety and outcomes throughout the perioperative period.

CONDITIONS

Brief Title

Mini-dose Dexmedetomidine-Esketamine Infusion and Perioperative Sleep Quality

Who Can Participate

Age: 65Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 65 years or older and less than 90 years
  • Scheduled to undergo unilateral knee or hip arthroplasty
Not Eligible

You will not qualify if you...

  • Refusal to participate
  • Use of hypnotic therapy for sleep disorders within the last 3 months
  • History of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis
  • Diagnosed obstructive sleep apnea or high risk of moderate to severe obstructive sleep apnea
  • Inability to communicate due to coma, severe dementia, or language barrier
  • Sick sinus syndrome, severe sinus bradycardia (heart rate less than 50 beats/min), or advanced atrioventricular block without pacemaker
  • Severe liver dysfunction (Child-Pugh class C), need for preoperative dialysis, or expected survival less than 24 hours
  • Current treatment with dexmedetomidine, clonidine, or esketamine
  • Allergy to dexmedetomidine or esketamine

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - From the night before surgery until 8 am on the third morning after surgery

Participants receive a mini-dose infusion of dexmedetomidine and esketamine or placebo starting the night before surgery and continuing until the third morning after surgery to improve sleep quality during the perioperative period.

1 infusion period covering the night before surgery through the third postoperative morning

Post-operative Follow-up

Duration - Up to 5 nights after surgery

Participants' sleep quality and recovery are monitored after the treatment period until the fifth night after surgery.

Visits to assess sleep quality and recovery during the follow-up period

Trial Site Locations

Total: 2 locations

1

Beijing Hospital

Beijing, Beijing Municipality, China, 100005

Actively Recruiting

2

Peking University First Hospital

Beijing, Beijing Municipality, China, 100034

Actively Recruiting

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Research Team

D

Dong-Xin Wang, MD,PhD

S

Shuang-Jie Cao, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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