postoperative delirium
Conditions
Interventions
Experimental Group (Dexmedetomidine Hydrochloride Nasal Spray Group, DEX Group) :In the experimental group, patients were administered dexmedetomidine hydrochloride nasal spray once before bedtime on
Control Group (0.9% Sodium Chloride Injection Nasal Spray Group, Placebo Group):given. The control group was given 0.9% sodium chloride solution nasal spray as a control.
Sponsors
He'nan Provincial People's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age >= 65 years; 2. Patients scheduled to undergo unilateral total hip arthroplasty, total knee arthroplasty, or gastrointestinal tumor surgery under general anesthesia; 3. ASA physical status classification II–III; 4. Signed informed consent form.
Exclusion criteria
Exclusion criteria: 1.History of mental illnesses (e.g., depression, schizophrenia, etc.); 2.History of neurological diseases (e.g., epilepsy, Parkinson's disease, etc.); 3.History of cerebrovascular accidents (stroke), traumatic brain injury, brain tumors, or other similar conditions; 4.Patients with cognitive impairment identified by the Mini-Mental State Examination (MMSE) score, adjusted for educational level; 5.Patients with acute nasal mucosal inflammation, injury, or anatomical abnormalities that may affect drug absorption; 6.Patients who have taken sleep-affecting medications (e.g., hypnotics, melatonin, etc.) in the past 3 months, or those with other sleep disorders; 7.History of alcohol dependence or drug dependence; 8.Patients with obstructive sleep apnea syndrome (OSAS) or at high risk of OSAS (STOP-Bang score >= 3 points); 9.Patients with severe asthma, severe emphysema, severe bronchitis, or severe chronic obstructive pulmonary disease (COPD); 10.Sick sinus syndrome, severe sinus bradycardia (heart rate 2 times the upper limit of the reference value; creatinine clearance [Ccr] 443 µmol/L); 13.Patients with severe visual, hearing, or reading impairments; 14.Patients who have participated in other relevant clinical studies within the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Postoperative Delirium(POD); | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of POD (days from diagnosis to CAM negativity);Sleep quality: Assessed by Pittsburgh Sleep Quality Index (PSQI) for sleep in the past month before surgery, and Richards-Campbell Sleep Questionnaire (RCSQ) for nighttime sleep on the morning of surgery;Anxiety status;Pain intensity;Opioid consumption;Postoperative hospital stay: The number of days from the end of the surgery to meeting the discharge criteria (the surgery day is counted as day 0, check the hospital's EMR system);Other postoperative complications;30-day all-cause mortality postoperatively (telephone follow-up); | — |
Countries
China
Contacts
Public ContactZhang Jiaqiang
He'nan Provincial People's Hospital
Outcome results
None listed