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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600128501
Enrollment
Unknown
Registered
2026-07-21
Start date
2026-09-01
Completion date
Unknown
Last updated
2026-08-03

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 aged =18 years scheduled for non-cardiac surgery under elective general anesthesia; 2.Diagnosis of hypertension: Blood pressure measured once daily for the first three days after admission, with all three readings =140/90 mmHg; or a prior diagnosis of hypertension with current antihypertensive medication use—even if blood pressure does not meet the above threshold; 3.NYHA Class I–III cardiac function; ASA Class I–III; 4.Voluntary participation and signed informed consent;

Exclusion criteria

Exclusion criteria: 1.History of prior cranial or spinal cord trauma and surgery, history of stroke, or inability to place electrodes on the head; 2.Patients with preoperative delirium or psychiatric disorders; 3.Patients with obstructive sleep apnea–hypopnea syndrome (OSAHS); 4.History of sleep disorder (use of hypnotics or sedatives within the past month); 5.tients admitted to the ICU after surgery; 6.The presence of cysts, tumors, or polyps in the respiratory tract, with a 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 sick sinus syndrome, decompensated heart failure, severe bradycardia (heart rate < 50 beats per minute), second-degree or higher atrioventricular block, permanent pacemaker implantation, and recent severe cardiovascular or cerebrovascular events; 9.Patients unable to complete the assessment as required by the scale cannot use the patient-controlled intravenous analgesia pump; 10.Individuals who have participated in other clinical trials;

Design outcomes

Primary

MeasureTime frame
postoperative sleep disturbances;

Secondary

MeasureTime frame
Ambulatory Blood Pressure Monitoring Results;Sleep Report Analysis;PSD-related indicators within 3 days postoperatively (sleep quality, pain, anxiety, depression, cognitive function, and 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+86 915 328 4365

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026