Effects of Low-dose Dexmedetomidine-esketamine Combined Nasal Administration at Night on Perioperative Sleep Quality in Breast Cancer Patients: a Randomized, Double-blind, Placebo-controlled Trial

2022-761

Breast cancer patients often have sleep disturbances during the perioperative period. Dexmedetomidine is a highly selective alpha 2-adrenoceptor agonist with sedative, anxiolytic, and analgesic effects. Previous studies showed that night-time low-dose dexmedetomidine infusion improved sleep quality. Esketamine is a N-methyl-D-aspartic acid receptor antagonist and has been used as an anesthetic and analgesic. Recent studies showed that low-dose esketamine has anti-depressive and sleep-promoting effects. The investigators suppose that low-dose dexmedetomidine-esketamine combined nasal administration at night can improve perioperative sleep quality in patients scheduled for breast cancer surgery.

2023-05-22

2024-03-01

2024-07-01

Recruiting

Early phase I

180

Inclusion Criteria: * Aged 50 years or older; * Diagnosed with breast cancer and scheduled for surgical resection; * Signed the informed consent form. Exclusion Criteria: * Not suitable for nasal administration because of nasal cavity diseases (rhinitis, nasal polyps, or nasal membrane congestion by any reason); * History of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis; * Unable to communicate due to coma, delirium, severe dementia, or language barrier before surgery; * History of intracranial injury or neurosurgery; * Taking sedative/hypnotics for sleep in the last month; * Preoperative sleep apnea (diagnosed with sleep apnea, or at high risk of sleep apnea according to STOP-Bang assessment); * History of hyperthyroidism and pheochromocytoma; * Preoperative LVEF\<30%; sick sinus syndrome, severe sinus bradycardia (heart rate\<50 beats/min), or atrioventricular block of degree II or higher without pacemaker; use vasopressors with systolic blood pressure \<90 mmHg; * Severe liver dysfunction (Child-Pugh C classification), severe renal dysfunction (dialysis before surgery), or Amercian Society of Anesthesiologists classification ≥IV; * Allergic to dexmedetomidine and/or esketamine, or other conditions that are considered unsuitable for study participation; * Body mass index \>30 kg/m2; * Enrolled in other clinical studies.

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2023-05-25