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A Randomized Controlled Trial Evaluating the Efficacy and Safety of Intranasal Dexmedetomidine for Postoperative Sleep Disorders

A Randomized Controlled Trial Evaluating the Efficacy and Safety of Intranasal Dexmedetomidine for Postoperative Sleep Disorders

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600129651
Enrollment
Unknown
Registered
2026-08-07
Start date
2026-09-01
Completion date
Unknown
Last updated
2026-08-10

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

Conditions

Postoperative sleep disturbances

Interventions

Sponsors

The First Affiliated Hospital of Xi'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1: Patients scheduled for elective orthopedic surgery under general anesthesia (aged >=18 years); 2: Cardiac function class I–III (NYHA classification) ,ASA physical status class I–III; 3: Voluntary participation and signed informed consent;

Exclusion criteria

Exclusion criteria: 1: History of prior traumatic brain or spinal cord injury and surgery, history of stroke, or inability to place electrodes on the head; 2: Preoperative delirium or psychiatric disorders; 3: Patients with obstructive sleep apnea-hypopnea syndrome (OSAHS); 4: History of sleep disorder (required use of hypnotics or sedatives within the past month); 5: Patients admitted to the ICU after surgery; 6: Presence of cysts, tumors, or polyps in the respiratory tract; history of upper respiratory tract infection within the past two weeks; 7: Severe hepatic and renal insufficiency (Child-Pugh class B or C; CKD stages 3–5); 8: Preoperative conditions include sinoatrial node dysfunction, decompensated heart failure, severe bradycardia (heart rate < 50 bpm), second-degree or higher atrioventricular block, permanent pacemaker implantation, and recent severe cardiovascular or cerebrovascular events;

Design outcomes

Primary

MeasureTime frame
Postoperative sleep disturbances;

Secondary

MeasureTime frame
Sleep Report Analysis;PSD-related indicators within 3 days postoperatively (sleep quality, pain, anxiety, depression, cognitive function, delirium scores, postoperative analgesic consumption, and adverse reactions);

Countries

China

Contacts

Public ContactGao Wei

The First Affiliated Hospital of Xi'an Jiaotong University

gaowei2906@xjtufh.edu.cn+86 915 3284365

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 25, 2026