Clinical trial · Interventional
Dexmedetomidine-esketamine Combined Nasal Administration and Perioperative Sleep Quality
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
NCT05732064CI-TRIAL-00092909completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Dexmedetomidine | — | UNRESOLVED | — |
| Esketamine | — | UNRESOLVED | — |
| Perioperative Period | — | UNRESOLVED | — |
| Sleep Quality | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexmedetomidine | Drug | — | UNRESOLVED |
| Esketamine | Drug | — | UNRESOLVED |
| Normal saline | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dexmedetomidine and esketamine
- description
- Dexmedetomidine 0.5 microgram/kg (300 microgram/ml) and esketamine 0.2 mg/kg (25 mg/ml) are administered via nasal cavity at 20:00 pm the day before surgery, the day of surgery, and the first day after surgery.
- interventionNames
- Drug: Dexmedetomidine
- Drug: Esketamine
- type
- PLACEBO_COMPARATOR
- label
- Normal saline
- description
- Same volumes of normal saline are administered via nasal cavity at 20:00 pm the day before surgery, the day of surgery, and the first day after surgery.
- interventionNames
- Drug: Normal saline
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
Show eligibility criteria text
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.
References
Publications (58)
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- BACKGROUNDLei S, Zheng R, Zhang S, Wang S, Chen R, Sun K, Zeng H, Zhou J, Wei W. Global patterns of breast cancer incidence and mortality: A population-based cancer registry data analysis from 2000 to 2020. Cancer Commun (Lond). 2021 Nov;41(11):1183-1194. doi: 10.1002/cac2.12207. Epub 2021 Aug 16. PMID 34399040
- BACKGROUNDBundred JR, Michael S, Stuart B, Cutress RI, Beckmann K, Holleczek B, Dahlstrom JE, Gath J, Dodwell D, Bundred NJ. Margin status and survival outcomes after breast cancer conservation surgery: prospectively registered systematic review and meta-analysis. BMJ. 2022 Sep 21;378:e070346. doi: 10.1136/bmj-2022-070346. PMID 36130770
- BACKGROUNDTsaras K, Papathanasiou IV, Mitsi D, Veneti A, Kelesi M, Zyga S, Fradelos EC. Assessment of Depression and Anxiety in Breast Cancer Patients: Prevalence and Associated Factors. Asian Pac J Cancer Prev. 2018 Jun 25;19(6):1661-1669. doi: 10.22034/APJCP.2018.19.6.1661. PMID 29938451
- BACKGROUNDCarreira H, Williams R, Muller M, Harewood R, Stanway S, Bhaskaran K. Associations Between Breast Cancer Survivorship and Adverse Mental Health Outcomes: A Systematic Review. J Natl Cancer Inst. 2018 Dec 1;110(12):1311-1327. doi: 10.1093/jnci/djy177.