Old AgeNCT05246007
Nocturnal Low-dose Dexmedetomidine Infusion and Perioperative Sleep Quality
A study testing Dexmedetomidine and Normal Saline in people with Old Age and Knee Replacement Surgery, run by Peking University First Hospital at 2 sites in China.
Trial summary
Sleep disturbances are prevalent in older patients with osteoarthrosis or fracture scheduled for knee or hip replacement surgery. The occurrence of sleep disturbances is associated with worse outcomes including increased risk of delirium and cardiac events, and worsened functional recovery. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Old Age, Knee Replacement Surgery, Hip Replacement Surgery
- What is being tested?
- Dexmedetomidine and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesChina
- Study dates
- May 2022to Dec 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥65 years and <90 years;
- Scheduled to undergo unilateral knee or hip arthroplasty under spinal or combined spinal-epidural anesthesia.
Who cannot join
- Refuse to participate;
- Hypnotic therapy for sleep disorders within 3 months;
- Presence of contraindications to intrathecal anesthesia;
- Preoperative history of schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis, or delirium;
- 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;
Show all 10Show fewer
- Sick sinus syndrome, severe sinus bradycardia (heart rate <50 beats/min), or atrioventricular block above grade II without pacemaker implanted;
- Severe hepatic dysfunction (Childe Pugh class C); renal dysfunction (required preoperative dialysis), or expected survival ≤24 hours;
- Receiving treatment with dexmedetomidine or clonidine;
- Allergy to dexmedetomidine.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Beijing Hospital
Beijing, Beijing Municipality, 100005
Peking University First Hospital
Beijing, Beijing Municipality, 100034
About this study
Official title: Effect of Nocturnal Low-dose Dexmedetomidine Infusion on Sleep Quality in Older Patients Undergoing Knee or Hip Replacement Surgery: A Multicenter Randomized Controlled Trial
Sleep disturbances are prevalent in older patients with osteoarthrosis or fracture scheduled for knee or hip replacement surgery. The occurrence of sleep disturbances is associated with worse outcomes including increased risk of delirium and cardiac events, and worsened functional recovery. Dexmedetomidine is a highly selective α2-adrenergic agonist with sedative, anxiolytic, and analgesic properties. It exerts sedative effects via activating the endogenous sleep pathways and produces a state like non-rapid eye movement sleep, which is different from opioid- and benzodiazepine-induced sedation. Night-time infusion of low-dose dexmedetomidine may improve sleep quality. However, evidence in this aspect is limited.
Read the detailed description
Sleep is a naturally recurring state characterized by lowered consciousness, reduced sensory and voluntary activity, and inhibited interaction with surroundings. Normal sleep has a particular structure and significant circadian rhythms; and is vital for both physical and mental health. Evidence shows that the restorative effect of sleep may be a consequence of the enhanced removal of potentially neurotoxic waste products like β-amyloid or tau protein via the glymphatic pathway in the neurological system.
Sleep disturbances frequently occur in elderly patients with chronic pain and complicated comorbidity. A meta-analysis shows that in adults, total sleep time, sleep efficiency, percentage of slow-wave sleep, and percentage of rapid eye movement (REM) sleep significantly decrease, while sleep latency, percentage of stage 1 non-REM sleep, percentage of stage 2 non-REM sleep, and wake after sleep onset significantly increase with ageing. Coexisting disease such as asthma and obstructive sleep apnea are also associated with poorer sleep quality, as manifested by increased stage 1 and 2 non-REM sleep, and decreased REM sleep. Furthermore, pain and sleep disturbances are closely correlated, and sleep disturbances frequently accompany pain from osteoarthritis (OA) or fracture in elderly patients who are scheduled for knee or hip arthroplasty.
Sleep disturbances are common after major surgery owing to preoperative comorbidity, residual anesthetic effects, surgical trauma, postoperative pain, use of analgesics, and hospital environment. Patients may report shortened total sleep time, increased number of arousals/awakenings, lowered subjective sleep quality, and sometimes nightmares. Polysomnographic monitoring reveals sleep deprivation, sleep fragmentation, altered sleep architecture (increased light sleep, decreased or disappeared deep and rapid eye movement sleep), and disordered circadian rhythm. Considering the importance of normal sleep for human health, it is not surprising that sleep disturbances may produce harmful effects on patients' recovery. Indeed, emerging evidence suggests that sleep disturbances are associated with increased sensitivity to pain, higher inflammation, more delirium, more cardiovascular events, and prolonged hospital stay.
Dexmedetomidine, an α2 adrenoceptor agonist with both sedative and analgesic properties, has increasingly been used. Unlike other sedative agents, dexmedetomidine exerts its sedative effects through an endogenous sleep-promoting pathway and preserves sleep architecture to some degree. In a recent study of mechanically ventilated ICU patients, nighttime infusion of a sedative dose of dexmedetomidine (median infusion rate 0.6 μg/kg/h [interquartile range, 0.4 to 0.7]) helped preserve the circadian of sleep and improved the sleep architecture by increasing sleep efficiency and stage 2 non-REM sleep. In our previous study of non-mechanically ventilated ICU patients, nighttime infusion of low-dose of dexmedetomidine (0.1 μg/kg/h) improved the sleep architecture by increasing sleep efficiency and stage 2 non-REM sleep. Our subsequent large randomized controlled trial showed that low-dose night-time infusion of dexmedetomidine improved sleep and decreased the incidence of delirium; furthermore, it improved 2-year survival and 3-year quality of life after surgery.
We suppose that, for older patients with osteoarthrosis or fracture who are scheduled for knee or hip replacement surgery, nighttime infusion of low-dose dexmedetomidine starting from the preoperative night and continuing in the postoperative period may improve sleep quality and postoperative recovery.
- Conditions
- Old Age, Knee Replacement Surgery, Hip Replacement Surgery, Dexmedetomidine, Sleep Quality
- Being tested
- Dexmedetomidine, Normal Saline
- Keywords
- Old Age, Knee replacement surgery, Hip replacement surgery, Dexmedetomidine, Sleep quality
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Dexmedetomidine for infusion
Dexmedetomidine will be infused at a rate of 0.02 ml/kg/h (0.025 μg/kg/h) during the night before surgery, the night of surgery, and the first 2 nights after surgery (from 9:00 pm-6:00 am).
Normal SalineDrug
Also called Normal Saline for infusion
Placebo (normal saline) will be infused at a rate of 0.02 ml/kg/h during the night before surgery, the night of surgery, and the first 2 nights after surgery (from 9:00 pm-6:00 am).
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine group | Experimental | Dexmedetomidine will be infused at a rate of 0.02 ml/kg/h (0.025 μg/kg/h) during the night before surgery, the night of surgery, and the first 2 nights after surgery (from 9:00 pm-6:00 am). Receives: Drug: Dexmedetomidine |
| Placebo group | Placebo comparator | Placebo (normal saline) will be infused at a rate of 0.02 ml/kg/h during the night before surgery, the night of surgery, and the first 2 nights after surgery (from 9:00 pm-6:00 am). Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective sleep quality (overall RCSQ score) during the night of surgery.
Subjective sleep quality will be assessed in the morning (between 8:00 am to 10:00 am) using the Richards-Campbell Sleep Questionnaire (RCSQ). The RCSQ is a self-reported measure that evaluated perception of nighttime sleep in five items, including sleep depth, sleep latency, number of awakenings, returning to sleep, and overall sleep quality. Each item was assessed with a 100-millimeter visual analog scale (VAS; score ranges from 0 to 100, with higher scores representing better sleep). The mean score of the five items represents the overall RCSQ score. The RCSQ also included a sixth item, not included in the overall score, that evaluated perceived nighttime noise (score ranges from 0 to 100, where 0="very noisy" and 100="very quiet").
Measured: During the night of surgery.
Secondary outcomes (17)
Subjective sleep quality (overall RCSQ score) during the perioperative period.
Subjective sleep quality will be assessed daily in the morning (between 8:00 am to 10:00 am) using the Richards-Campbell Sleep Questionnaire (RCSQ).
Measured: From the night before surgery until the fifth night after surgery.
Total sleep time per night during the perioperative period.
Objective sleep quality will be monitored with an actigraphy from 6:00 pm to 8:00 am from the night before surgery until the fifth night after surgery. Total sleep time is defined as the sum in time scored as asleep.
Measured: From the night before surgery until the fifth night after surgery.
Sleep efficiency per night during the perioperative period.
Objective sleep quality will be monitored with an actigraphy from 6:00 pm to 8:00 am from the night before surgery until the fifth night after surgery. Sleep efficiency is defined as 100*total sleep time/time in bed.
Measured: From the night before surgery until the fifth night after surgery.
Sleep onset latency per night during the perioperative period.
Objective sleep quality will be monitored with an actigraphy from 6:00 pm to 8:00 am from the night before surgery until the fifth night after surgery. Sleep onset latency is defined as time difference between time to bed and sleep start.
Measured: From the night before surgery until the fifth night after surgery.
Wake after sleep onset per night during the perioperative period.
Objective sleep quality will be monitored with an actigraphy from 6:00 pm to 8:00 am from the night before surgery until the fifth night after surgery. Wake after sleep onset is defined as the total time scored as awake between sleep start and sleep end.
Measured: From the night before surgery until the fifth night after surgery.
Intensity of pain during the first 3 postoperative days.
Intensity of pain will be assessed at 6, 12, 24, 48, and 72 hours after surgery with the Numeric Rating Scale (an 11-point scale where 0 indicates no pain and 10 the worst pain)
Measured: Up to 3 days after surgery.
The incidence of delirium within 5 days after surgery.
Delirium is assessed twice daily (8:00-10:00 am and 6:00-8:00 pm) with the 3-minute diagnostic interview for Confusion Assessment Method-defined delirium (3D-CAM).
Measured: Up to 5 days after surgery.
The joint range of motion after surgery.
Range of motion is assessed between 8:00 am to 10:00 am at 1, 3, and 5 days after surgery.
Measured: Up to 5 days after surgery.
Length of stay in hospital after surgery.
Length of stay in hospital after surgery.
Measured: Up to 30 days after surgery.
Incidence of non-delirium complications within 30 days.
Non-delirium complications are defined as newly occurred medical events other than delirium that are deemed harmful and required therapeutic intervention, i.e., grade II or higher on the Clavien-Dindo classification.
Measured: Up to 30 days after surgery.
Subjective sleep quality (Pittsburgh Sleep Quality Index) at 30 days after surgery.
Subjective sleep quality at 30 days after surgery will be assessed with the Pittsburgh Sleep Quality Index. This is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score.
Measured: On the 30th day after surgery.
Cognitive function at 3 months after surgery.
Cognitive function is assessed with the modified Telephone Interview for Cognitive Status.
Measured: At the end of the 3rd month after surgery.
Quality of life at 3 months after surgery.
Quality of life is assessed with short form 36 questionnaire.
Measured: At the end of the 3rd month after surgery.
3-year overall survival.
Overall survival is defined as the time interval from surgery to all-cause death.
Measured: Up to 3 years after surgery.
3-year event-free survival.
Event-free survival is defined as the time interval from surgery to the earliest date of new serious disease (require hospitalization) or all-cause death.
Measured: Up to 3 years after surgery.
Cognitive function within 3 years after surgery.
Cognitive function will be assessed at the end of each year after surgery, with the modified Telephone Interview for Cognitive Status.
Measured: Up to 3 years after surgery.
Quality of life every year within 3 years after surgery.
Quality of life will be assessed at the end of each year after surgery, with short form 36 questionnaire.
Measured: Up to 3 years after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study startMay 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2026 (estimated)
Why it stopped: We changed the protocol and registered for another trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Old AgeStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Hospital
- Responsible party
- Principal investigator, Dong-Xin Wang, Peking University First Hospital
- Investigators
- Dong-Xin Wang, MD, PhD, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05246007
- Sponsor's protocol ID
- 2021-639
- Status last verified
- Jul 2025
- First submitted
- 8 Feb 2022
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Siegel JM. Sleep viewed as a state of adaptive inactivity. Nat Rev Neurosci. 2009 Oct;10(10):747-53. doi: 10.1038/nrn2697. Epub 2009 Aug 5.
PubMed 19654581Xie L, Kang H, Xu Q, Chen MJ, Liao Y, Thiyagarajan M, O'Donnell J, Christensen DJ, Nicholson C, Iliff JJ, Takano T, Deane R, Nedergaard M. Sleep drives metabolite clearance from the adult brain. Science. 2013 Oct 18;342(6156):373-7. doi: 10.1126/science.1241224.
PubMed 24136970Onen SH, Onen F, Courpron P, Dubray C. How pain and analgesics disturb sleep. Clin J Pain. 2005 Sep-Oct;21(5):422-31. doi: 10.1097/01.ajp.0000129757.31856.f7.
PubMed 16093748Lintzeris N, Moodley R, Campbell G, Larance B, Bruno R, Nielsen S, Degenhardt L. Sleep Quality Among People Living With Chronic Noncancer Pain: Findings From the Pain and Opioids IN Treatment (POINT) Cohort. Clin J Pain. 2016 May;32(5):380-7. doi: 10.1097/AJP.0000000000000282.
PubMed 26218004Er MS, Altinel EC, Altinel L, Erten RA, Eroglu M. An assessment of sleep quality in patients undergoing total knee arthroplasty before and after surgery. Acta Orthop Traumatol Turc. 2014;48(1):50-4. doi: 10.3944/AOTT.2014.3163.
PubMed 24643100Sasaki E, Tsuda E, Yamamoto Y, Maeda S, Inoue R, Chiba D, Okubo N, Takahashi I, Nakaji S, Ishibashi Y. Nocturnal knee pain increases with the severity of knee osteoarthritis, disturbing patient sleep quality. Arthritis Care Res (Hoboken). 2014 Jul;66(7):1027-32. doi: 10.1002/acr.22258.
PubMed 24470323Fatah RMN, Abdulrahman BB. A sleep disturbance after total knee arthroplasty. J Family Med Prim Care. 2020 Jan 28;9(1):119-124. doi: 10.4103/jfmpc.jfmpc_595_19. eCollection 2020 Jan.
PubMed 32110576Alexopoulou C, Kondili E, Diamantaki E, Psarologakis C, Kokkini S, Bolaki M, Georgopoulos D. Effects of dexmedetomidine on sleep quality in critically ill patients: a pilot study. Anesthesiology. 2014 Oct;121(4):801-7. doi: 10.1097/ALN.0000000000000361.
PubMed 24988068Wu XH, Cui F, Zhang C, Meng ZT, Wang DX, Ma J, Wang GF, Zhu SN, Ma D. Low-dose Dexmedetomidine Improves Sleep Quality Pattern in Elderly Patients after Noncardiac Surgery in the Intensive Care Unit: A Pilot Randomized Controlled Trial. Anesthesiology. 2016 Nov;125(5):979-991. doi: 10.1097/ALN.0000000000001325.
PubMed 27571256Su X, Meng ZT, Wu XH, Cui F, Li HL, Wang DX, Zhu X, Zhu SN, Maze M, Ma D. Dexmedetomidine for prevention of delirium in elderly patients after non-cardiac surgery: a randomised, double-blind, placebo-controlled trial. Lancet. 2016 Oct 15;388(10054):1893-1902. doi: 10.1016/S0140-6736(16)30580-3. Epub 2016 Aug 16.
PubMed 27542303Zhang DF, Su X, Meng ZT, Li HL, Wang DX, Xue-Ying Li, Maze M, Ma D. Impact of Dexmedetomidine on Long-term Outcomes After Noncardiac Surgery in Elderly: 3-Year Follow-up of a Randomized Controlled Trial. Ann Surg. 2019 Aug;270(2):356-363. doi: 10.1097/SLA.0000000000002801.
PubMed 29742525Li HJ, Li CJ, Wei XN, Hu J, Mu DL, Wang DX. Dexmedetomidine in combination with morphine improves postoperative analgesia and sleep quality in elderly patients after open abdominal surgery: A pilot randomized control trial. PLoS One. 2018 Aug 14;13(8):e0202008. doi: 10.1371/journal.pone.0202008. eCollection 2018.
PubMed 30106963
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nocturnal Low-dose Dexmedetomidine Infusion on Sleep Quality in Older Patients Undergoing Knee or Hip Replacement Surgery: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05246007
- Acronym / sponsor ID
- 2021-639
- Conditions
- Old Age, Knee Replacement Surgery, Hip Replacement Surgery, Dexmedetomidine, Sleep Quality
- Keywords
- Old Age, Knee replacement surgery, Hip replacement surgery, Dexmedetomidine, Sleep quality
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We changed the protocol and registered for another trial.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Collaborators
- Beijing Hospital
- Study start
- May 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 18 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sleep disturbances are prevalent in older patients with osteoarthrosis or fracture scheduled for knee or hip replacement surgery. The occurrence of sleep disturbances is associated with worse outcomes including increased risk of delirium and cardiac events, and worsened functional recovery. Dexmedetomidine is a highly selective α2-adrenergic agonist with sedative, anxiolytic, and analgesic properties. It exerts sedative effects via activating the endogenous sleep pathways and produces a state like non-rapid eye movement sleep, which is different from opioid- and benzodiazepine-induced sedation. Night-time infusion of low-dose dexmedetomidine may improve sleep quality. However, evidence in this aspect is limited.
Detailed description
Sleep is a naturally recurring state characterized by lowered consciousness, reduced sensory and voluntary activity, and inhibited interaction with surroundings. Normal sleep has a particular structure and significant circadian rhythms; and is vital for both physical and mental health. Evidence shows that the restorative effect of sleep may be a consequence of the enhanced removal of potentially neurotoxic waste products like β-amyloid or tau protein via the glymphatic pathway in the neurological system.
Sleep disturbances frequently occur in elderly patients with chronic pain and complicated comorbidity. A meta-analysis shows that in adults, total sleep time, sleep efficiency, percentage of slow-wave sleep, and percentage of rapid eye movement (REM) sleep significantly decrease, while sleep latency, percentage of stage 1 non-REM sleep, percentage of stage 2 non-REM sleep, and wake after sleep onset significantly increase with ageing. Coexisting disease such as asthma and obstructive sleep apnea are also associated with poorer sleep quality, as manifested by increased stage 1 and 2 non-REM sleep, and decreased REM sleep. Furthermore, pain and sleep disturbances are closely correlated, and sleep disturbances frequently accompany pain from osteoarthritis (OA) or fracture in elderly patients who are scheduled for knee or hip arthroplasty.
Sleep disturbances are common after major surgery owing to preoperative comorbidity, residual anesthetic effects, surgical trauma, postoperative pain, use of analgesics, and hospital environment. Patients may report shortened total sleep time, increased number of arousals/awakenings, lowered subjective sleep quality, and sometimes nightmares. Polysomnographic monitoring reveals sleep deprivation, sleep fragmentation, altered sleep architecture (increased light sleep, decreased or disappeared deep and rapid eye movement sleep), and disordered circadian rhythm. Considering the importance of normal sleep for human health, it is not surprising that sleep disturbances may produce harmful effects on patients' recovery. Indeed, emerging evidence suggests that sleep disturbances are associated with increased sensitivity to pain, higher inflammation, more delirium, more cardiovascular events, and prolonged hospital stay.
Dexmedetomidine, an α2 adrenoceptor agonist with both sedative and analgesic properties, has increasingly been used. Unlike other sedative agents, dexmedetomidine exerts its sedative effects through an endogenous sleep-promoting pathway and preserves sleep architecture to some degree. In a recent study of mechanically ventilated ICU patients, nighttime infusion of a sedative dose of dexmedetomidine (median infusion rate 0.6 μg/kg/h [interquartile range, 0.4 to 0.7]) helped preserve the circadian of sleep and improved the sleep architecture by increasing sleep efficiency and stage 2 non-REM sleep. In our previous study of non-mechanically ventilated ICU patients, nighttime infusion of low-dose of dexmedetomidine (0.1 μg/kg/h) improved the sleep architecture by increasing sleep efficiency and stage 2 non-REM sleep. Our subsequent large randomized controlled trial showed that low-dose night-time infusion of dexmedetomidine improved sleep and decreased the incidence of delirium; furthermore, it improved 2-year survival and 3-year quality of life after surgery.
We suppose that, for older patients with osteoarthrosis or fracture who are scheduled for knee or hip replacement surgery, nighttime infusion of low-dose dexmedetomidine starting from the preoperative night and continuing in the postoperative period may improve sleep quality and postoperative recovery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine group | Experimental | Drug: DexmedetomidineDexmedetomidine will be infused at a rate of 0.02 ml/kg/h (0.025 μg/kg/h) during the night before surgery, the night of surgery, and the first 2 nights after surgery (from 9:00 pm-6:00 am). |
| Placebo group | Placebo comparator | Drug: Normal SalinePlacebo (normal saline) will be infused at a rate of 0.02 ml/kg/h during the night before surgery, the night of surgery, and the first 2 nights after surgery (from 9:00 pm-6:00 am). |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Age ≥65 years and <90 years;
- Scheduled to undergo unilateral knee or hip arthroplasty under spinal or combined spinal-epidural anesthesia.
Key exclusion criteria (10 listed)
- Refuse to participate;
- Hypnotic therapy for sleep disorders within 3 months;
- Presence of contraindications to intrathecal anesthesia;
- Preoperative history of schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis, or delirium;
- Diagnosed as obstructive sleep apnea, or at high risk of moderate to severe obstructive sleep apnea according to the STOP-Bang questionnaire;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineAlso: Dexmedetomidine for infusionDexmedetomidine will be infused at a rate of 0.02 ml/kg/h (0.025 μg/kg/h) during the night before surgery, the night of surgery, and the first 2 nights after surgery (from 9:00 pm-6:00 am). | Drug | Dexmedetomidine group |
| Normal SalineAlso: Normal Saline for infusionPlacebo (normal saline) will be infused at a rate of 0.02 ml/kg/h during the night before surgery, the night of surgery, and the first 2 nights after surgery (from 9:00 pm-6:00 am). | Drug | Placebo group |
Primary outcome
Subjective sleep quality (overall RCSQ score) during the night of surgery.
Time frame: During the night of surgery.
Subjective sleep quality will be assessed in the morning (between 8:00 am to 10:00 am) using the Richards-Campbell Sleep Questionnaire (RCSQ). The RCSQ is a self-reported measure that evaluated perception of nighttime sleep in five items, including sleep depth, sleep latency, number of awakenings, returning to sleep, and overall sleep quality. Each item was assessed with a 100-millimeter visual analog scale (VAS; score ranges from 0 to 100, with higher scores representing better sleep). The mean score of the five items represents the overall RCSQ score. The RCSQ also included a sixth item, not included in the overall score, that evaluated perceived nighttime noise (score ranges from 0 to 100, where 0="very noisy" and 100="very quiet").
17 secondary outcomes
Subjective sleep quality (overall RCSQ score) during the perioperative period.
Time frame: From the night before surgery until the fifth night after surgery.
Total sleep time per night during the perioperative period.
Time frame: From the night before surgery until the fifth night after surgery.
Sleep efficiency per night during the perioperative period.
Time frame: From the night before surgery until the fifth night after surgery.
Sleep onset latency per night during the perioperative period.
Time frame: From the night before surgery until the fifth night after surgery.
Wake after sleep onset per night during the perioperative period.
Time frame: From the night before surgery until the fifth night after surgery.
Intensity of pain during the first 3 postoperative days.
Time frame: Up to 3 days after surgery.
The incidence of delirium within 5 days after surgery.
Time frame: Up to 5 days after surgery.
The joint range of motion after surgery.
Time frame: Up to 5 days after surgery.
Length of stay in hospital after surgery.
Time frame: Up to 30 days after surgery.
Incidence of non-delirium complications within 30 days.
Time frame: Up to 30 days after surgery.
Subjective sleep quality (Pittsburgh Sleep Quality Index) at 30 days after surgery.
Time frame: On the 30th day after surgery.
Cognitive function at 3 months after surgery.
Time frame: At the end of the 3rd month after surgery.
Quality of life at 3 months after surgery.
Time frame: At the end of the 3rd month after surgery.
3-year overall survival.
Time frame: Up to 3 years after surgery.
3-year event-free survival.
Time frame: Up to 3 years after surgery.
Cognitive function within 3 years after surgery.
Time frame: Up to 3 years after surgery.
Quality of life every year within 3 years after surgery.
Time frame: Up to 3 years after surgery.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Background: PubMed 19654581Siegel JM. Sleep viewed as a state of adaptive inactivity. Nat Rev Neurosci. 2009 Oct;10(10):747-53. doi: 10.1038/nrn2697. Epub 2009 Aug 5.
- Background: PubMed 24136970Xie L, Kang H, Xu Q, Chen MJ, Liao Y, Thiyagarajan M, O'Donnell J, Christensen DJ, Nicholson C, Iliff JJ, Takano T, Deane R, Nedergaard M. Sleep drives metabolite clearance from the adult brain. Science. 2013 Oct 18;342(6156):373-7. doi: 10.1126/science.1241224.
- Background: PubMed 16093748Onen SH, Onen F, Courpron P, Dubray C. How pain and analgesics disturb sleep. Clin J Pain. 2005 Sep-Oct;21(5):422-31. doi: 10.1097/01.ajp.0000129757.31856.f7.
- Background: PubMed 26218004Lintzeris N, Moodley R, Campbell G, Larance B, Bruno R, Nielsen S, Degenhardt L. Sleep Quality Among People Living With Chronic Noncancer Pain: Findings From the Pain and Opioids IN Treatment (POINT) Cohort. Clin J Pain. 2016 May;32(5):380-7. doi: 10.1097/AJP.0000000000000282.
- Background: PubMed 24643100Er MS, Altinel EC, Altinel L, Erten RA, Eroglu M. An assessment of sleep quality in patients undergoing total knee arthroplasty before and after surgery. Acta Orthop Traumatol Turc. 2014;48(1):50-4. doi: 10.3944/AOTT.2014.3163.
- Background: PubMed 24470323Sasaki E, Tsuda E, Yamamoto Y, Maeda S, Inoue R, Chiba D, Okubo N, Takahashi I, Nakaji S, Ishibashi Y. Nocturnal knee pain increases with the severity of knee osteoarthritis, disturbing patient sleep quality. Arthritis Care Res (Hoboken). 2014 Jul;66(7):1027-32. doi: 10.1002/acr.22258.
- Background: PubMed 32110576Fatah RMN, Abdulrahman BB. A sleep disturbance after total knee arthroplasty. J Family Med Prim Care. 2020 Jan 28;9(1):119-124. doi: 10.4103/jfmpc.jfmpc_595_19. eCollection 2020 Jan.
- Background: PubMed 24988068Alexopoulou C, Kondili E, Diamantaki E, Psarologakis C, Kokkini S, Bolaki M, Georgopoulos D. Effects of dexmedetomidine on sleep quality in critically ill patients: a pilot study. Anesthesiology. 2014 Oct;121(4):801-7. doi: 10.1097/ALN.0000000000000361.
- Background: PubMed 27571256Wu XH, Cui F, Zhang C, Meng ZT, Wang DX, Ma J, Wang GF, Zhu SN, Ma D. Low-dose Dexmedetomidine Improves Sleep Quality Pattern in Elderly Patients after Noncardiac Surgery in the Intensive Care Unit: A Pilot Randomized Controlled Trial. Anesthesiology. 2016 Nov;125(5):979-991. doi: 10.1097/ALN.0000000000001325.
- Background: PubMed 27542303Su X, Meng ZT, Wu XH, Cui F, Li HL, Wang DX, Zhu X, Zhu SN, Maze M, Ma D. Dexmedetomidine for prevention of delirium in elderly patients after non-cardiac surgery: a randomised, double-blind, placebo-controlled trial. Lancet. 2016 Oct 15;388(10054):1893-1902. doi: 10.1016/S0140-6736(16)30580-3. Epub 2016 Aug 16.
- Background: PubMed 29742525Zhang DF, Su X, Meng ZT, Li HL, Wang DX, Xue-Ying Li, Maze M, Ma D. Impact of Dexmedetomidine on Long-term Outcomes After Noncardiac Surgery in Elderly: 3-Year Follow-up of a Randomized Controlled Trial. Ann Surg. 2019 Aug;270(2):356-363. doi: 10.1097/SLA.0000000000002801.
- Background: PubMed 30106963Li HJ, Li CJ, Wei XN, Hu J, Mu DL, Wang DX. Dexmedetomidine in combination with morphine improves postoperative analgesia and sleep quality in elderly patients after open abdominal surgery: A pilot randomized control trial. PLoS One. 2018 Aug 14;13(8):e0202008. doi: 10.1371/journal.pone.0202008. eCollection 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dong-Xin Wang, MD, PhD principal investigator
Peking University First Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine and Normal Saline in people with Old Age and Knee Replacement Surgery, run by Peking University First Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective sleep quality (overall RCSQ score) during the night of surgery. (time frame: During the night of surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05246007, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.