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Breast CancerPhase 4NCT05732064

Dexmedetomidine-esketamine Combined Nasal Administration and Perioperative Sleep Quality

A Phase 4 study testing Dexmedetomidine, Esketamine and Normal saline in people with Breast Cancer and Perioperative Period, run by Peking University First Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older, women only
What is being tested?
Dexmedetomidine, Esketamine and Normal saline
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
180 participants
Where
1 siteChina
Study dates
22 May 2023to 26 Jul 2025
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 50 years or older;
  • Diagnosed with breast cancer and scheduled for surgical resection;
  • Signed the informed consent form.

Who cannot join

  • 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);
Show all 12Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking University First Hospital

    Beijin, Bejing, 100034

Other trials in China

About this study

Official title: 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

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.

Read the detailed description

Normal sleep is important for maintaining both physical and mental health. Patients who are scheduled for breast cancer surgery often have sleep disturbances during the perioperative period. Patients with persistent sleep disturbances have increased sensitivity to pain and are at increased risk of developing chronic postsurgical pain.

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 improves sleep quality. Nasal administration of dexmedetomidine has been used in children as a premedication and in adults to reduce emergence agitation.

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. Nasal administration of esketamine has been used in children to relieve pain and in adults for treatment-resistant depression.

This randomized trial is designed to test the hypothesis that combined nasal administration of low-dose dexmedetomidine-esketamine at night can improve perioperative sleep quality in patients scheduled for breast cancer surgery.

Being tested
Dexmedetomidine, Esketamine, Normal saline
Keywords
Breast Cancer, Perioperative period, Dexmedetomidine, Esketamine, Sleep quality
Medical subject headings
Breast Neoplasms, Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexmedetomidineDrug

    Dexmedetomidine 0.5 microgram/kg (300 microgram/ml) is administered via nasal cavity at 20:00 pm the day before surgery, the day of surgery, and the first day after surgery.

  • EsketamineDrug

    Esketamine 0.2 mg/kg (25 mg/ml) is administered via nasal cavity at 20:00 pm the day before surgery, the day of surgery, and the first day after surgery.

  • Normal salineDrug

    Normal saline of same volume is administered via nasal cavity at 20:00 pm the day before surgery, the day of surgery, and the first day after surgery.

Study groups in NCT05732064
Study groupRoleWhat they receive
Dexmedetomidine and esketamineExperimentalDexmedetomidine 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.
Receives: Drug: Dexmedetomidine; Drug: Esketamine
Normal salinePlacebo comparatorSame 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.
Receives: Drug: Normal saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Subjective sleep quality (the night of surgery)

    Subjective sleep quality is assessed with the Richards-Campbell Sleep Questionnaire (RCSQ). RCSQ is a self-reported measure that evaluated perception of nighttime sleep in five items, including sleep depth, sleep latency, number of awakenings, returning to sleep, and overall sleep quality. Each item was assessed with a 100-millimeter visual analog scale (score ranges from 0 to 100, with higher scores representing better sleep). The mean score of the five items represents the overall RCSQ score.

    Measured: The night on the day of surgery

Secondary outcomes (7)

  1. Subjective sleep quality (the night before and the first night after surgery)

    Subjective sleep quality if assessed with the RCSQ. RCQS is a self-reported measure that evaluated perception of nighttime sleep in five items, including sleep depth, sleep latency, number of awakenings, returning to sleep, and overall sleep quality. Each item was assessed with a 100-millimeter visual analog scale (score ranges from 0 to 100, with higher scores representing better sleep). The mean score of the five items represents the overall RCSQ score.

    Measured: The night before surgery and the first night after surgery

  2. Objective sleep quality - total sleep time

    Objective sleep quality is assessed with the actigraphy.

    Measured: The night before surgery, the night on the day of surgery, and the first night after surgery

  3. Objective sleep quality - sleep efficiency

    Objective sleep quality is assessed with the actigraphy.

    Measured: The night before surgery, the night on the day of surgery, and the first night after surgery

  4. Objective sleep quality - sleep latency

    Objective sleep quality is assessed with the actigraphy.

    Measured: The night before surgery, the night on the day of surgery, and the first night after surgery

  5. Objective sleep quality - wake-up time after falling asleep

    Objective sleep quality is assessed with the actigraphy.

    Measured: The night before surgery, the night on the day of surgery, and the first night after surgery

  6. Intensity of acute pain

    Intensity of acute pain is assessed with the numeric rating scale, an 11-point scale where 0=no pain and 10=the worst pain.

    Measured: At 2 hours after surgery and twice daily during the first 2 postoperative days

  7. Subjective sleep quality at 30 days

    Subjective sleep quality at 30 days is assessed with the Pittsburgh Sleep Quality Index (PSQI). PSQI is a 7-item questionnaire consisting 19 self-rated questions that assesses sleep quality over the last month, each weighted equally on a 0-3 scale; higher scores indicate worse sleep quality.

    Measured: At 30 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Feb 2023
  2. Study start22 May 2023
  3. Primary completion20 Apr 2025
  4. Study completion26 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05732064
Sponsor's protocol ID
2022-761
Status last verified
Jul 2025
First submitted
29 Jan 2023
Last updated
31 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sancho-Garnier H, Colonna M. [Breast cancer epidemiology]. Presse Med. 2019 Oct;48(10):1076-1084. doi: 10.1016/j.lpm.2019.09.022. Epub 2019 Nov 6. French.

    PubMed 31706896

  • Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.

    PubMed 30207593

  • Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.

    PubMed 26808342

  • Lei 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.

    PubMed 34399040

  • Bundred 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.

    PubMed 36130770

  • Tsaras 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.

    PubMed 29938451

  • Carreira 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.

    PubMed 30403799

  • Kwak A, Jacobs J, Haggett D, Jimenez R, Peppercorn J. Evaluation and management of insomnia in women with breast cancer. Breast Cancer Res Treat. 2020 Jun;181(2):269-277. doi: 10.1007/s10549-020-05635-0. Epub 2020 Apr 20.

    PubMed 32314110

  • Fleming L, Randell K, Stewart E, Espie CA, Morrison DS, Lawless C, Paul J. Insomnia in breast cancer: a prospective observational study. Sleep. 2019 Mar 1;42(3):zsy245. doi: 10.1093/sleep/zsy245.

    PubMed 30521041

  • Siegel JM. Sleep viewed as a state of adaptive inactivity. Nat Rev Neurosci. 2009 Oct;10(10):747-53. doi: 10.1038/nrn2697. Epub 2009 Aug 5.

    PubMed 19654581

  • Hungs M. Fundamentals of sleep medicine [J]. JAMA, 2012, 307(12): 1320-1321.

  • Mansano-Schlosser TC, Ceolim MF, Valerio TD. Poor sleep quality, depression and hope before breast cancer surgery. Appl Nurs Res. 2017 Apr;34:7-11. doi: 10.1016/j.apnr.2016.11.010. Epub 2016 Nov 17.

    PubMed 28342628

  • Su X, Wang DX. Improve postoperative sleep: what can we do? Curr Opin Anaesthesiol. 2018 Feb;31(1):83-88. doi: 10.1097/ACO.0000000000000538.

    PubMed 29120927

  • Fekih-Romdhane F, Achouri L, Hakiri A, Jaidane O, Rahal K, Cheour M. Hopelessness is associated with poor sleep quality after breast cancer surgery among Tunisian women. Curr Probl Cancer. 2020 Feb;44(1):100504. doi: 10.1016/j.currproblcancer.2019.100504. Epub 2019 Sep 17.

    PubMed 31548046

  • Shammas RL, Marks CE, Broadwater G, Le E, Glener AD, Sergesketter AR, Cason RW, Rezak KM, Phillips BT, Hollenbeck ST. The Effect of Lavender Oil on Perioperative Pain, Anxiety, Depression, and Sleep after Microvascular Breast Reconstruction: A Prospective, Single-Blinded, Randomized, Controlled Trial. J Reconstr Microsurg. 2021 Jul;37(6):530-540. doi: 10.1055/s-0041-1724465. Epub 2021 Feb 6.

    PubMed 33548936

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dexmedetomidine, Esketamine and Normal saline in people with Breast Cancer and Perioperative Period, run by Peking University First Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subjective sleep quality (the night of surgery) (time frame: The night on the day of surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05732064, which also lists 58 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.

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