Clinical Trials Logo

Clinical 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. 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT05246007
Study type Interventional
Source Peking University First Hospital
Contact Dong-Xin Wang, MD, PhD
Phone 86 10 83572784
Email wangdongxin@hotmail.com
Status Not yet recruiting
Phase N/A
Start date May 2022
Completion date December 2026

See also
  Status Clinical Trial Phase
Completed NCT04577430 - Effects of Dexmedetomidine on Cardiac Electrophysiology in Patients Under General Anesthesia During Perioperative Period N/A
Completed NCT03220880 - Intranasal Dexmedetomidine Sedation in Children for Non-painful Procedures
Completed NCT05291364 - Dexmedetomidine in Splanchnic Nerve Neurolysis N/A
Recruiting NCT05249153 - Dexmedetomidine and Sufentanil Effect in PCA on Pediatric Patients Undergoing Scoliosis Surgery N/A
Completed NCT01688648 - Comparison Between Lidocaine, Dexmedetomidine, and Their Combined Infusion in Subjects Undergoing Coronary Artery Bypass Graft N/A
Completed NCT05103735 - Propofol-remifentanyl Versus Dexmedetomidine in Awake Craniotomy: Impact on Electroclinical Seizure Activity
Recruiting NCT06030804 - Perioperative Dexmedetomidine and Long-term Survival After Cancer Surgery N/A
Terminated NCT03253224 - Magnesium and Postoperative Pain Phase 4
Recruiting NCT06210061 - Propofol-Fentanyl-Dexmedetomidine and Propofol-Fentanyl-Sevoflurane Anesthesia for Major Spine Surgery Under Somato Sensory- and Motor- Evoked Potential Monitoring N/A
Recruiting NCT05525819 - Intrathecal Versus Intravenous Dexmedetomidine in Prostate Transurethral Resection N/A
Completed NCT04665453 - Dexmedetomidine and Melatonin for Sleep Induction for EEG in Children N/A
Completed NCT06018948 - Effect of Two Different Doses of Dexmedetomidine Infusion in Morbidly Obese Patients Phase 4
Completed NCT03775655 - Low Dose Hyperbaric Bupivacaine and Dexmedetomidine as an Adjuvant, Caesarean Section Phase 2/Phase 3
Completed NCT03658421 - Dexmedetomidine as Adjuvant for FNB in TKA N/A
Completed NCT03234660 - Dexmedetomidine and Neuroprotection in Children Undergoing General Anesthesia N/A
Completed NCT06020781 - Efficacy and Safety of Dexmedetomidine to Bupivacaine in Supraclavicular Brachial Plexus Block N/A
Recruiting NCT06207331 - Effects of Atomized Dexmedetomidine on Lung Function in Patients With Chronic Obstructive Pulmonary Disease N/A
Active, not recruiting NCT03629262 - Dexmedetomidine Supplemented Intravenous Analgesia in Elderly After Orthopedic Surgery Phase 4
Completed NCT06098209 - Dexmedetomidine and Propofol in Mechanically Ventilated Patients by Using Salivary Alpha-amylase as a Stress Marker N/A
Not yet recruiting NCT06062550 - Different Dose Esketamine and Dexmedetomidine Combination for Supplemental Analgesia After Scoliosis Correction Surgery Phase 4