Dexmedetomidine-esketamine Combined Nasal Administration and Perioperative Sleep Quality

• Status: Not yet recruiting
• Trial end date: 2024-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University First Hospital
• Treatments: Dexmedetomidine; Esketamine

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.