Sleep quilty
Conditions
Interventions
Trial Group (Dexmedetomidine Nasal Spray Group):From the 1st to the 3rd night after surgery, dexmedetomidine nasal spray 50µg per dose (one spray) was administered intranasally 30 minutes before bedti
Control Group (Alprazolam Group):Oral alprazolam 0.4mg, once every night before bed or after getting into bed from day 1 to day 3 post - operation, for 3 consecutive days. Before administration, confi
Sponsors
The Seventh Affiliated Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18-80 years, regardless of gender, with clear cognitive and communication abilities to cooperate in completing subjective sleep assessments and device monitoring. 2.Scheduled for elective orthopedic surgery (anesthesia method: general anesthesia or neuraxial anesthesia; local anesthesia excluded), requiring postoperative hospitalization for =3 days to ensure sufficient time for early postoperative sleep quality monitoring and intervention effect evaluation. Orthopedic surgery types are limited to routine surgeries for the spine, joints, trauma, and bone tumors, with an expected operation duration of 45 minutes to 5 hours (inclusive of 45 minutes and 5 hours). 3. Postoperative consistent analgesia with local ropivacaine plus tramadol. 4. Preoperative Pittsburgh Sleep Quality Index (PSQI) score =7 points, excluding patients with chronic preoperative sleep disorders to avoid confounding of intervention effect judgment by baseline sleep issues. 5. American Society of Anesthesiologists (ASA) physical status classification ?-?, with stable underlying health conditions and no severe dysfunction of major organs such as the heart, liver, or kidneys, to reduce the risk of adverse events during the study. 6. Patients and their family members fully understand the study purpose, intervention plan, and potential risks, voluntarily sign the informed consent form, and commit to complying with all study requirements (e.g., cooperating with device wearing, completing assessments on time).
Exclusion criteria
Exclusion criteria: 1.Hypersensitivity to dexmedetomidine, excipients of the nasal spray, or oral sleep-aiding drugs in the control group. 2. Severe preoperative sleep disorders (PSQI score >7 points), history of insomnia (diagnosed for >3 months), or long-term use of sedative-hypnotic drugs (>=3 times per week for >1 month). 3. Severe cardiovascular diseases, such as sick sinus syndrome, grade ?-? atrioventricular block (without pacemaker implantation), recent myocardial infarction or heart failure (within 6 months). Dexmedetomidine may cause bradycardia and hypotension, which may exacerbate the condition in such patients. 4. Severe respiratory diseases, such as acute exacerbation of chronic obstructive pulmonary disease, respiratory failure (requiring mechanical ventilation), to avoid potential effects of the drug on respiratory function. 5. Cognitive impairment (e.g., Alzheimer's disease, history of postoperative delirium), mental illness (e.g., depression, anxiety not stably controlled), or inability to cooperate in completing subjective sleep assessments and device monitoring. 6. Abnormal nasal structure (e.g., severe nasal polyps, deviated nasal septum, acute inflammation of nasal mucosa) that affects nasal spray absorption. 7. Use of sedative-hypnotic drugs or opioid analgesics (dosage > routine preoperative analgesic dosage) within 24 hours before surgery, or long-term use of other drugs that may affect sleep after surgery (e.g., glucocorticoids, antidepressants). 8. Pregnant or lactating women, or other conditions that may lead to unreliable study data (e.g., expected transfer out of the orthopedic ward within 24 hours after surgery, inability to complete full follow-up). 9. Elective orthopedic surgery under local anesthesia, expected operation duration 5 hours (inclusive); orthopedic surgery types are non-routine (e.g., scoliosis correction, complex radical resection of bone tumors, etc., beyond the scope of routine surgeries for the spine, joints, trauma, and bone tumors).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Richards-Campbell Sleep Questionnaire(RCSQ); | — |
Secondary
| Measure | Time frame |
|---|---|
| Sleep structure sub-indicators (including duration of N3 stage, duration of REM stage, sleep efficiency, number and total duration of awakenings, subjective sleep latency, frequency of subjective sleep interruptions, Pittsburgh Sleep Quality Index [PSQI] score);Pain control indicators (including pain score VAS, total opioid consumption converted to morphine equivalent dose); | — |
Countries
China
Contacts
Public ContactLiu Zheng
The Seventh Affiliated Hospital, Sun Yat-sen University
Outcome results
None listed