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The effect of dexmedetomidine nasal drops on postoperative sleep status and delirium in elderly patients with mild preoperative sleep disorders and gastrointestinal tumors

The effect of dexmedetomidine nasal drops on postoperative sleep status and delirium in elderly patients with mild preoperative sleep disorders and gastrointestinal tumors

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600121449
Enrollment
Unknown
Registered
2026-03-31
Start date
2026-04-10
Completion date
Unknown
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative delirium

Interventions

Control group:Receive 1ml of nasal saline solution at 20:00 the night before surgery and 30 minutes before anesthesia induction on the day of surgery, with 0.5ml in each nasal cavity.
Dexmedetomidine group:Dilute with 0.9% sodium chloride injection under sterile conditions to 50 µ g/ml before administration. Administer dexmedetomidine nasal drops at 20:00 on the evening of the day

Sponsors

Sichuan Gem Flower Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >= 65 years old; 2. Planned elective radical surgery for gastrointestinal tumors; 3. ASA grading I-III; 4. Preoperative Pittsburgh Sleep Quality Index (PSQI) total score>5; 5. Voluntarily sign an informed consent form and be able to cooperate in completing follow-up and evaluation.

Exclusion criteria

Exclusion criteria: 1. Previous mental or neurological disorders (dementia, Parkinson's disease, epilepsy, etc.) or long-term use of sedatives/antipsychotic drugs; 2. Alcohol or drug dependence; 3. Severe liver, kidney, heart, lung dysfunction or active hemorrhagic disease; 4. Severe bradycardia (HR= 15) or obstructive sleep apnea syndrome; 7. Serious nasal diseases that are contraindicated for nasal administration or affect drug absorption.

Design outcomes

Primary

MeasureTime frame
The incidence of postoperative delirium;

Secondary

MeasureTime frame
Pittsburgh Sleep Quality Index Score;Deep sleep ratio;Shallow sleep ratio;Proportion of rapid eye movement ;Number of awakenings;Deep Sleep Continuity Score;Overall Sleep Quality Score;The concentration of cortisol in saliva;Concentration of alpha amylase in saliva;The concentration of melatonin in saliva;Concentration of immunoglobulin A in saliva;

Countries

China

Contacts

Public ContactLinli Tang

Sichuan Gem Flower Hospital

275886216@qq.com+86 183 2845 4968

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026