Back to resultsDexmedetomidine-esketamine Combined Nasal Administration and Perioperative Sleep Quality
Primary Purpose
Breast Cancer, Perioperative Period, Dexmedetomidine
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Dexmedetomidine
Esketamine
Normal saline
Sponsored by
About this trial
This is an interventional prevention trial for Breast Cancer focused on measuring Breast Cancer, Perioperative period, Dexmedetomidine, Esketamine, Sleep quality
Eligibility 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.
Sites / Locations
- Peking University First HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Dexmedetomidine and esketamine
Normal saline
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Objective sleep quality - total sleep time
Objective sleep quality is assessed with the actigraphy.
Objective sleep quality - sleep efficiency
Objective sleep quality is assessed with the actigraphy.
Objective sleep quality - sleep latency
Objective sleep quality is assessed with the actigraphy.
Objective sleep quality - wake-up time after falling asleep
Objective sleep quality is assessed with the actigraphy.
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.
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.
Full Information
NCT ID
NCT05732064
First Posted
January 29, 2023
Last Updated
May 23, 2023
Sponsor
Peking University First Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05732064
Brief Title
Dexmedetomidine-esketamine Combined Nasal Administration and Perioperative Sleep Quality
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 22, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University First Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Perioperative Period, Dexmedetomidine, Esketamine, Sleep Quality
Keywords
Breast Cancer, Perioperative period, Dexmedetomidine, Esketamine, Sleep quality
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dexmedetomidine and esketamine
Arm Type
Experimental
Arm 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.
Arm Title
Normal saline
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
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
Intervention Name(s)
Esketamine
Intervention Description
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
Intervention Name(s)
Normal saline
Intervention Description
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.
Primary Outcome Measure Information:
Title
Subjective sleep quality (the night of surgery)
Description
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.
Time Frame
The night on the day of surgery
Secondary Outcome Measure Information:
Title
Subjective sleep quality (the night before and the first night after surgery)
Description
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.
Time Frame
The night before surgery and the first night after surgery
Title
Objective sleep quality - total sleep time
Description
Objective sleep quality is assessed with the actigraphy.
Time Frame
The night before surgery, the night on the day of surgery, and the first night after surgery
Title
Objective sleep quality - sleep efficiency
Description
Objective sleep quality is assessed with the actigraphy.
Time Frame
The night before surgery, the night on the day of surgery, and the first night after surgery
Title
Objective sleep quality - sleep latency
Description
Objective sleep quality is assessed with the actigraphy.
Time Frame
The night before surgery, the night on the day of surgery, and the first night after surgery
Title
Objective sleep quality - wake-up time after falling asleep
Description
Objective sleep quality is assessed with the actigraphy.
Time Frame
The night before surgery, the night on the day of surgery, and the first night after surgery
Title
Intensity of acute pain
Description
Intensity of acute pain is assessed with the numeric rating scale, an 11-point scale where 0=no pain and 10=the worst pain.
Time Frame
At 2 hours after surgery and twice daily during the first 2 postoperative days
Title
Subjective sleep quality at 30 days
Description
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.
Time Frame
At 30 days after surgery
Other Pre-specified Outcome Measures:
Title
Use of supplemental analgesics
Description
Include opioids and non-opioid analgesics.
Time Frame
Within the first 2 days after surgery
Title
Severity of anxiety
Description
Anxiety is assessed with the Generalized Anxiexy Disorde-7 (GAD-7). GAD-7 contains 7 items assessing the core symptoms of anxiety. Patients rate their frequency of symptoms within the last two weeks on a four-point scale ranging from "not at all" to "almost every day". Scores range from 0 to 21, with higher scores indicating more severe anxiety.
Time Frame
Before hospital discharge
Title
Severity of depression
Description
Depression is assessed with the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 includes 9-item requiring responses of 0 (not at all) to 3 (nearly every day) to assess the occurrence of depressive symptoms over the last two weeks. It has 8 items on depressive symptoms and 1 focused on suicidal ideation. Total scores range from 0 to 27, with higher score indicating more severe symptoms.
Time Frame
Before hospital discharge
Title
Length of hospital stay after surgery
Description
Length of hospital stay after surgery
Time Frame
Up to 30 days after surgery
Title
Occurrence of postoperative complications
Description
Postoperative complications are defined as new-onset medical events that are deemed harmful and required therapeutic intervention, that is grade II or higher on the Clavien-Dindo classification.
Time Frame
Up to 30 days after surgery
Title
Occurrence of Chronic Postoperative Pain
Description
Chronic Postoperative Pain (CPSP) is defined as pain persisted for at least three months after surgery, that was not present before surgery or that had different characteristics, and other possible causes of the pain were excluded (e.g., cancer recurrence, infection).
Time Frame
At 3 months after surgery
Title
Severity of chronic pain
Description
Severity of chronic pain is assessed with the Brief Pain Inventory (BPI). The BPI gives two main scores: a pain severity score and a pain interference score. The pain severity score is calculated from the four items about pain intensity. Each item is rated from 0, no pain, to 10, pain as bad as you can imagine, and contributes with the same weight to the final score, ranging from 0 to 40.
Time Frame
At 3 months after surgery
Title
Interference of chronic pain
Description
Interference of chronic pain is assessed with the Brief Pain Inventory (BPI). The BPI gives two main scores: a pain severity score and a pain interference score. The pain interference score corresponds to the item on pain interference. The seven subitems are rated from 0, does not interfere, to 10, completely interferes, and contributes with the same weight to the final score, ranging from 0 to 70.
Time Frame
At 3 months after surgery
Title
Life quality assessed with the EORTC QLQ-BR53 (part of EORTC-C30)
Description
Quality of life is assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Breast Cancer 53 (EORTC QLQ-BR53), including European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC-C30) and EORTC-BR23. EORTC QLQ-C30 contains 30 items (items 29 and 30 are classified into 7 degrees regarding to patients' response, scoring from 1 to 7; remaining items are divided into 4 degrees, including "Not at all", "A little", "Quite a bit", and "Very much", with a score from 1 to 4). All patient rated scores are linearly converted into a scale from 0 to 100 for analysis. Higher scores represent worse QoL on symptom aspects, whereas higher scores on functional interference correlate with better function.
Time Frame
At 3 months after surgery
Title
Life quality assessed with the EORTC QLQ-BR53 (part of EORTC-BR23)
Description
Quality of life is assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Breast Cancer 53 (EORTC QLQ-BR53), including European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC-C30) and EORTC-BR23. EORTC QLQ-BR23 contains 23 items. Each item used a 4-point Likert scale (i.e. "not at all", "a little", "quite a bit", and "very much"). All patient rated scores are linearly converted into a scale from 0 to 100 for analysis. Higher scores represent worse QoL on symptom aspects, whereas higher scores on functional interference correlate with better function.
Time Frame
At 3 months after surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dong-Xin Wang, MD, PhD
Phone
83572784
Email
wangdongxin@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jia-Hui Ma, PhD
Email
mjh@bjmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong-Xin Wang, MD, PhD
Organizational Affiliation
Peking University First Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University First Hospital
City
Beijin
State/Province
Bejing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong-Xin Wang, MD, PhD
Phone
86(10) 83572784
Email
wangdongxin@hotmail.com
First Name & Middle Initial & Last Name & Degree
Jia-Hui Ma, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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Dexmedetomidine-esketamine Combined Nasal Administration and Perioperative Sleep Quality
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