Nighttime drug cocktail aims to help seniors sleep better after joint surgery
NCT ID NCT05950646
First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time
Summary
This trial tests whether a very low dose of two drugs—dexmedetomidine and esketamine—given at night can improve sleep quality in older adults (65-89 years) undergoing knee or hip replacement. Poor sleep after surgery is common and linked to worse recovery. The study compares the drug combination to a placebo, measuring sleep quality through questionnaires and wearable monitors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Dexmedetomidine and Esketamine
- What this could lead to
- If effective, this could offer a simple way to improve sleep and recovery for older patients after joint replacement surgery.
- What could go wrong
- This is a small, early-phase trial, and the drugs may not improve sleep or could cause side effects like low blood pressure or nausea.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
154 people
The number who actually took part.
- Started
-
Jan 2024
- Finished
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Apr 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
65 to 90 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥65 years and \<90 years; * Scheduled to undergo unilateral knee or hip arthroplasty. Exclusion Criteria: * Refuse to participate; * Hypnotic therapy for sleep disorders within 3 months; * Preoperative history of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis; * Diagnosed as obstructive sleep apnea, or at high risk of moderate to severe obstructive sleep apnea according to the Stop-Bang questionnaire; * Inability to communicate in the preoperative period because of coma, profound dementia, or language barrier; * Sick sinus syndrome, severe sinus bradycardia (heart rate \<50 beats/min), or atrioventricular block above grade II without pacemaker implanted; * Severe hepatic dysfunction (Child-Pugh class C), renal dysfunction (required preoperative dialysis), or expected survival ≤24 hours; * Receiving treatment with dexmedetomidine, clonidine, or esketamine; * Allergy to dexmedetomidine or esketamine.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Beijing Hospital
Beijing, Beijing Municipality, 100005, China
-
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
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