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Lemborexant for Sleep and Delirium Prevention in Elderly ICU Patients

RecruitingPhase 4Ages 65 Years - anyAllMahidol University
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In plain words

What the trial is, and whether it could suit you

Sleep disturbance is very common among critically ill patients in the intensive care unit (ICU), particularly in older adults after surgery. Poor sleep in the ICU is associated with important complications, including delirium, longer duration of mechanical ventilation, prolonged hospital stay, and increased mortality. Current non-drug approaches to improve sleep, such as reducing noise and light and clustering nursing care, may provide limited benefit and are often difficult to implement consistently. Safe and effective drug treatments for sleep in critically ill older patients remain limited. Lemborexant is a dual orexin receptor antagonist that promotes sleep by blocking wake-promoting pathways in the brain. Unlike many traditional sleep medications, lemborexant has minimal effects on breathing and has been shown to be well tolerated in older adults with insomnia. However, its effects

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age 65 years or older. * Admission to the Surgical Intensive Care Unit (SICU). * Anticipated ICU stay of at least 48 hours, as assessed by the ICU consultant and responsible surgeon. * Able to receive enteral medication via oral or nasogastric route. Exclusion Criteria: * Requirement for frequent neurological checks or scheduled awakening (e.g., acute stroke or neurosurgery). * Deep sedation defined as Richmond Agitation-Sedation Scale (RASS) โ‰ค -3. * Positive Confusion Assessment Method for the ICU (CAM-ICU) within 12 hours prior to randomization. * Severe hemodynamic or respiratory instability requiring neuromuscular blockers or high-dose vasopressors (e.g., norepinephrine โ‰ฅ 0.1 ยตg/kg/min and titrating upward). * High risk of aspiration, including ongoing vomiting, gastric residual volume \>250 mL, or intolerance to oral or enteral medications. * Concomitant use of strong CYP3A inhibitors or inducers (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, rifampicin, carbamazepine, phenytoin, or St. John's wort). * Severe hepatic impairment (Child-Pugh class C). * End-stage kidney disease or chronic kidney disease stage 5. * Concomitant use of sedative-hypnotic medications, including benzodiazepines, Z-drugs, trazodone, tricyclic antidepressants, melatonin, or other sleep-inducing agents. * Known hypersensitivity to lemborexant or other dual orexin receptor antagonists. * History of cataplexy-like symptoms or severe depression with suicidal ideation.
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What it tests

  • Lemborexant
  • Placebo
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Where

1 site
Siriraj Hospital
Bangkok, Thailand
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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