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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
180
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.
Peking University First Hospital
Beijin, Bejing, China
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.
Time frame: The night on the day of surgery
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.
Time frame: The night before surgery and the first night after surgery
Objective sleep quality - total sleep time
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 - sleep efficiency
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 - sleep latency
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 - wake-up time after falling asleep
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
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.
Time frame: At 2 hours after surgery and twice daily during the first 2 postoperative days
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.
Time frame: At 30 days after surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.