Dexmedetomidine-esketamine Combined Nasal Administration and Perioperative Sleep Quality
NCT ID: NCT05732064
Last Updated: 2025-07-31
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE4
Total Enrollment
180 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-05-22
Study Completion Date
2025-07-26
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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Breast Cancer
Perioperative Period
Dexmedetomidine
Esketamine
Sleep Quality
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
PREVENTION
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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Dexmedetomidine and esketamine
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.
Group Type
EXPERIMENTAL
Dexmedetomidine
Intervention Type
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.
Esketamine
Intervention Type
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.
Normal saline
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.
Group Type
PLACEBO_COMPARATOR
Normal saline
Intervention Type
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.
Interventions
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Dexmedetomidine
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.
Intervention Type
DRUG
Esketamine
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.
Intervention Type
DRUG
Normal saline
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.
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* Aged 50 years or older;
* Diagnosed with breast cancer and scheduled for surgical resection;
* Signed the informed consent form.
* 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.
* 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.
Minimum Eligible Age
50 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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Peking University First Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Dong-Xin Wang
Professor and chairman, Department of Anesthesiology
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Dong-Xin Wang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Peking University First Hospital
Locations
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Peking University First Hospital
Beijin, Bejing, China
Site Status
Countries
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China
References
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Reference Type
BACKGROUND
Werner MU, Kongsgaard UE. I. Defining persistent post-surgical pain: is an update required? Br J Anaesth. 2014 Jul;113(1):1-4. doi: 10.1093/bja/aeu012. Epub 2014 Feb 18. No abstract available.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2022-761
Identifier Type: -
Identifier Source: org_study_id
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