Dexmedetomidine-esketamine Combined Nasal Administration and Perioperative Sleep Quality

NCT05732064 | Completed Phase 4 DMC

• 1 other identifier: 2022-761
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; Perioperative Period; Dexmedetomidine; Esketamine; Sleep Quality

Keywords

Breast Cancer; Perioperative period; Dexmedetomidine; Esketamine; Sleep quality

Outcome Measures

Primary Outcomes (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.

  The night on the day of surgery

Secondary Outcomes (7)

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

  The night before surgery and the first night after surgery

• Objective sleep quality - total sleep time

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

• Objective sleep quality - sleep efficiency

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

• Objective sleep quality - sleep latency

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

• Objective sleep quality - wake-up time after falling asleep

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

Other Outcomes (10)

• Use of supplemental analgesics

  Within the first 2 days after surgery

• Severity of anxiety

  Before hospital discharge

• Severity of depression

  Before hospital discharge

Study Arms (2)

Dexmedetomidine and esketamine

EXPERIMENTAL

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.

Drug: Dexmedetomidine; Drug: Esketamine

Normal saline

PLACEBO COMPARATOR

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.

Drug: Normal saline

Interventions

Dexmedetomidine DRUG

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.

Dexmedetomidine and esketamine

Esketamine DRUG

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.

Dexmedetomidine and esketamine

Normal saline DRUG

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.

Normal saline

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijin, Bejing, 100034, China

Location

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MeSH Terms

Conditions

Breast Neoplasms; Sleep Initiation and Maintenance Disorders

Interventions

Dexmedetomidine; Esketamine; Saline Solution

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Dong-Xin Wang, MD, PhD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and chairman, Department of Anesthesiology

Study Record Dates

• First Submitted: January 29, 2023
• First Posted: February 16, 2023
• Study Start: May 22, 2023
• Primary Completion: April 20, 2025
• Study Completion: July 26, 2025
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)