Peking University First Hospital
Beijin, Bejing, 100034, China
NCT Number: NCT05732064
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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Notify Me50 year and older
Female
Interventional
Phase 4
Beijin, Bejing, 100034, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 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 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.
Time frame: The night on the day 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.
Time frame: The night before surgery 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.
Time frame: The night before surgery, the night on the day of surgery, and the first night after surgery
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
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
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
Objective sleep quality is assessed with the actigraphy.
Time frame: At 2 hours after surgery and twice daily during the first 2 postoperative days
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 30 days after surgery
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: Within the first 2 days after surgery
Include opioids and non-opioid analgesics.
Time frame: Before hospital discharge
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
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: Up to 30 days after surgery
Length of hospital stay after surgery
Time frame: Up to 30 days after surgery
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: At 3 months after surgery
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
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
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
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
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.
Peking University First Hospital
Other
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
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