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Effect of dexmedetomidine on insomnia disorder during perioperative period in patients undergoing knee replacement

Effect of dexmedetomidine on insomnia disorder during perioperative period in patients undergoing knee replacement

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500099812
Enrollment
Unknown
Registered
2025-03-28
Start date
2024-05-14
Completion date
Unknown
Last updated
2025-03-31

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

Conditions

Insomnia disorder

Interventions

B group:Dexmedetomidine was injected with 0.05ug/kg/h pump at 21:00 on the night after surgery until 9:00 am the next day
C group:At 21:00 on the night after surgery, the same volume of normal saline was used to spray the nose in the same way
A group:1ug/kg dexmedetomidine hydrochloride nasal spray was used at 21:30 the night after surgery

Sponsors

The Third Affiliated Hospital of Guangzhou University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Age 50-80 years old, gender is not limited; 2.ASA grade I to III, unilateral total knee replacement was selected, the anesthesia method was lumbo-epidural anesthesia; 3.PSQI score >=7, and meet the DSM-5 diagnostic criteria for insomnia disorder; 4.No patients with mental illness; 5.I or family members sign the study informed consent;

Exclusion criteria

Exclusion criteria: 1.Patients allergic to dexmedetomidine, patients with chronic sinusitis and other nasal diseases; 2.Respiratory history: history of severe chronic obstructive pulmonary disease, acute onset of chronic obstructive pulmonary disease, severe airway stenosis, throat mass, (branch) tracheoesophageal fistula, or airway tear, and severe respiratory infection within nearly 2 weeks prior to screening; 3.Cardiovascular history: uncontrolled hypertension [systolic blood pressure (SBP)>170mmHg and/or diastolic blood pressure (DBP)>105mmHg without antihypertensive drugs, Or SBP>160mmHg and/or DBP>100mmHg], aneurysm, severe arrhythmia, heart failure, Adams-stokes syndrome, New York Heart Association (NYHA) heart function grade >III, severe superior vena cava obstruction Syndrome, pericardial effusion, acute myocardial ischemia, unstable angina pectoris, myocardial infarction in the last 6 months prior to screening, history of tachycardia/bradycardia requiring medical treatment, degree II-III atrioventricular block (excluding pacemakers); 4.Liver, kidney, lung and other organ lesions serious; 5.Patients with central nervous system disorders, patients with sleep apnea syndrome and patients with other types of sleep disorders;

Design outcomes

Primary

MeasureTime frame
Pittsburgh Sleep Quality Index;Polysomnography;

Secondary

MeasureTime frame
Psychomotor alertness test;Visual analog scale pain rating;Athens Insomnia Scale;

Countries

China

Contacts

Public ContactHuang Ziqi

The Third Affiliated Hospital of Guangzhou University of Chinese Medicine

hzq13078218560@163.com+86 13078218560

Outcome results

None listed

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