Postoperative delirium (POD)
Conditions
Interventions
Control group:An equal volume of sterile 0.9% NaCl was administered intranasally before surgery
Dexmedetomidine Hydrochloride Nasal Spray Group:Dexmedetomidine Hydrochloride nasal spray was administered preoperatively
Exploring the effective dose groups(Part 1):Dexmedetomidine nasal spray
Sponsors
Zhejiang Provincial People's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 65 years and above; 2. Planning to undergo non-cardiac surgery under general anesthesia; 3. ASA classification I to III; 4. Estimated surgery time greater than 1 hour; 5. Expected postoperative hospital stay of 2 days or more.
Exclusion criteria
Exclusion criteria: 1.Patients diagnosed with delirium preoperatively using the 3D-CAM scale; 2.Cognitive impairment was defined by education-stratified MMSE cutoffs: =IV; 6.Cardiac or cranial surgery; 7.Sick sinus syndrome, clinically significant sinus bradycardia, or second-degree or higher heart block without a pacemaker; 8.Severe hepatic insufficiency (Child-Pugh class C); 9.Patients requiring preoperative dialysis; 10.Allergy to a2-adrenergic agonists; 11.History of nasal conditions, surgeries, or allergies judged by the investigator to be clinically significant and severely affecting drug absorption (e.g., chronic nasal congestion, rhinorrhea, epistaxis; structural nasal abnormalities or mucosal lesions impairing absorption); 12.Emergency surgery; 13.Any other condition deemed by the investigator to render the patient unsuitable for the trial (e.g., inability to maintain the required position for dexmedetomidine nasal spray administration: sitting or semi-recumbent); 14.Enrollment in other clinical trials during the screening period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative delirium (POD) incidence;Number of intranasal sprays of dexmedetomidine hydrochloride (Part 1).;Positive or negative reaction(Part1); | — |
Secondary
| Measure | Time frame |
|---|---|
| Intraoperative anesthetic consumption, and postoperative pain outcomes";Preoperative anxiety and stress levels;Postoperative recovery profile;ICU admission rates;Major Complications Within 30 Days Postoperatively;Postoperative pain profile;Vital signs;Subjective sleep quality;Postoperative Hospital Stay Duration;Operative Duration;Vital signs (Part1);Time to first achieve a Ramsay Sedation Score >= 3 (Part 1).;Adverse events(Part1); | — |
Countries
China
Contacts
Public ContactLuo Foquan
Zhejiang Provincial People's Hospital
Outcome results
None listed