Postoperative decline in sleep quality
Conditions
Interventions
Intranasal dexmedetomidine placebo + oral melatonin:From 1 day before the operation to 3 days after the operation, dexmedetomidine placebo (1.5 µg/kg) was administered intranasally at 21:00 every nigh
Intranasal dexmedetomidine + oral melatonin:From 1 day before the operation to 3 days after the operation, dexmedetomidine (1.5 µg/kg) was administered intranasally at 21:00 every night + melatonin (1
Intranasal dexmedetomidine placebo + oral melatonin placebo:From 1 day before the operation to 3 days after the operation, dexmedetomidine placebo (1.5 µg/kg) was administered intranasally at 21:00 ev
Intranasal dexmedetomidine + oral melatonin placebo:From 1 day before the operation to 3 days after the operation, dexmedetomidine (1.5 µg/kg) was administered intranasally at 21:00 every night + mela
Sponsors
Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1.18 years old <= age <85 years old; 2. ASA grades I - III; 3. Major non-cardiac surgeries are scheduled to be performed; 4. Voluntarily sign the informed consent form;
Exclusion criteria
Exclusion criteria: 1.Have serious mental disorders; 2.Suffer from serious central nervous system disorders such as Parkinson's disease, Alzheimer's disease, etc; 3.Were pharamacologically treated for insomnia within 6 weeks; 4.Resting heart rate (HR) is <50 bpm; 5.Are having emergency or trauma surgery; 6.Planned postoperative admission to the intensive care unit (ICU) after surgery; 7.Have a history of POD or postoperative cognitive decline; 8.Have hearing or vision impairments likely to interfere with trial assessments; 9.Have severe systemic comorbidities such as cardiac dysfunction, malignant arrhythmias, malignant hypertension, hepatic failure, or renal failure; 10.Have contraindications to dexmedetomidine or melatonin; 11.Are participating in a conflicting trial; 12.Previous participation in other clinical trials;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adherence rate of intranasal dexmedetomidine or placebo combined with oral melatonin or placebo administered over the 5-day perioperative period; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse reactions of dexmedetomidine or melatonin treatment;Availability rate of clinical outcome data;subjective sleep quality within the first 3 postoperative days;objective sleep quality within the first 3 postoperative days; | — |
Countries
China
Contacts
Public ContactLi Peiying
Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed