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Not Yet Recruiting NCT05732064

Dexmedetomidine-esketamine Combined Nasal Administration and Perioperative Sleep Quality

Conditions: Breast Cancer, Perioperative Period, Dexmedetomidine, Esketamine, Sleep Quality

Sex: Female
Ages: 50 Years – N/A
Phase: PHASE4
Enrollment: 180
Sponsor: Peking University First Hospital

Summary

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.

Eligibility Criteria

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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Source: ClinicalTrials.gov (NCT05732064). StuddyBuddy aggregates publicly available trial information.