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Effect of dexmedetomidine nasal spray on perioperative sleep quality in elderly patients

Effect of dexmedetomidine nasal spray on perioperative sleep quality in elderly patients undergoing laparoscopic tumor resection

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200065202
Enrollment
Unknown
Registered
2022-10-31
Start date
2022-11-01
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Perioperative sleep disturbance

Interventions

Sponsors

Beijing Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 200 Years

Inclusion criteria

Inclusion criteria: (1) Age>=65 years (2) Planned laparoscopic elective tumor resection; (3) Informed and signed consent form; (4) ASA Grade I-III; (5) The patient was admitted at least 2 days prior to the operation, and the expected postoperative hospital stay was 4 days or more.

Exclusion criteria

Exclusion criteria: (1) Patients with contraindications of nasal administration such as skull base fracture and cerebrospinal fluid leakage; (2) dexmedetomidine allergy; (3) Patients with the following arrhythmias: severe sinus bradycardia (heart rate < 50 times/min), grade II or above atrioventricular block without pacemaker implantation, sick sinus syndrome; (4) Patients with sleep apnea syndrome or B-APNEIC scale score of 3 or above; (5) Long-term use of psychotropic drugs or alcohol dependence; (6) had taken prescription sleeping drugs within 2 weeks before participating in the study; (7) require or have received dexmedetomidine or clonidine in addition to participating in the study; (8) Unable to communicate due to coma, dementia or speech disorder; (9) Preoperative delirium, mental illness (schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis, etc.); (10) Patients who intend to undergo surgery via nasal route; (11) Abnormal sleep habits: go to bed before 21:00 or fall asleep after 2am; (12) Patients had moderate to severe pain (VAS score of 4 or above) affecting sleep. (13) Severe liver function impairment: serum total bilirubin =34.2umol/L or Child-Pugh grade C; (14) Severe renal impairment: GFR=60 or receiving dialysis before surgery; (15) Postoperative transfer to ICU was planned

Design outcomes

Primary

MeasureTime frame
QOS on the night of surgery;

Secondary

MeasureTime frame
perioperative QOS;perioperative GTS score;perioperative AFS score;perioperative BFW score;objective parameters;anxiety;cognitive function;quality of life;Pain;delirium;sedation;long term sleep;living condition;

Countries

China

Contacts

Public ContactZhen Liu

Beijing Hospital

luckyliuzhen@126.com+86 13261937073

Outcome results

None listed

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