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Evaluation of the Effect of Dexmedetomidine Nasal Spray on Sleep and Postoperative Neurocognitive Function in Elderly Patients with Sleep Disorder

Evaluation of the Effect of Dexmedetomidine Nasal Spray on Sleep and Postoperative Neurocognitive Function in Elderly Patients with Sleep Disorder

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300077614
Enrollment
Unknown
Registered
2023-11-14
Start date
2023-11-14
Completion date
Unknown
Last updated
2025-02-10

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

Conditions

perioperative neurocognitive disorders

Interventions

Dex group :The patients are instructed to spray a loading dose of Dex into each nostril, 1-3 sprays per nostril, 30 minutes before bedtime. If the patient is still unable to fall asleep after 30 minut
Control group:In the control group, physiological saline is used instead of Dex and filled into the bottle (with no visual difference in appearance) as a placebo. 30 minutes before bedtime on the nigh

Sponsors

The Affiliated Hospital of Guizhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Patients scheduled for elective non-cardiac surgery under general anesthesia; 2. Anticipated surgery duration of >= 2 hours; 3. Aged >= 60 years; 4. Pittsburgh Sleep Quality Index (PSQI) score > 7; 5. Understanding of the informed consent form and agreement to participate in the study; 6. Ability to participate in neuropsychological testing with a Mini-Mental State Examination (MMSE) score >24.

Exclusion criteria

Exclusion criteria: 1. Allergy to the investigational drug; 2. Heart rate = IV; 5. Inability to receive nasal drug administration due to nasal, pharyngeal, or oral diseases; 6. Presence of severe neurological (e.g., stroke, intracranial tumors) or psychiatric disorders (e.g., schizophrenia, affective disorders); 7. Day surgeries or intracranial surgeries; 8. Patient withdrawal during the study period.

Design outcomes

Primary

MeasureTime frame
postoperative delirium incidence;

Secondary

MeasureTime frame
incidence of delayed postoperative neurocognitive recovery;sleep quality;

Countries

China

Contacts

Public ContactJing Shi

The Affiliated Hospital of Guizhou Medical University

315585290@qq.com+86 186 8503 4016

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026