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Observation on the Efficacy of Dexmedetomidine Nasal Spray in Improving Sleep Quality in Patients Undergoing Lower Limb Orthopedic Surgery

Observation on the Efficacy of Dexmedetomidine Nasal Spray in Improving Sleep Quality in Patients Undergoing Lower Limb Orthopedic Surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125049
Enrollment
Unknown
Registered
2026-05-20
Start date
2026-06-05
Completion date
Unknown
Last updated
2026-05-25

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

Conditions

Postoperative sleep disorders

Interventions

Group A (Single-dose administration group):30 minutes before surgery, sit upright with head slightly tilted backward, nasal spray administered by trained medical staff, 1 spray in each nostril, wait 3
Group B (Fractionated administration group):30 minutes before surgery, sit upright with head slightly tilted backward, nasal spray administered by trained medical staff, 1 spray in each nostril, total
Group C (Conventional anesthesia group):Conventional anesthesia group (standard general anesthesia without intranasal dexmedetomidine).

Sponsors

Affiliated Qingyuan Hospital, Guangzhou Medical University (Qingyuan People's Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Approved by the Ethics Committee of our hospital, patients and their families have given informed consent and voluntarily participated in this study. 2.(2)Aged 20-75 years old, regardless of gender, with a body mass index (BMI) of 18.0-28.0 kg/m² and American Society of Anesthesiologists (ASA) classification of Grade I-III. 3.(3)Scheduled to undergo elective general anesthesia for lower limb orthopedic surgery (such as total hip arthroplasty, total knee arthroplasty, open reduction and internal fixation of lower limb fractures), with an operation time of 1.5-3 hours. 4.(4)Preoperative Mini-Mental State Examination (MMSE) score = 24 points, normal cognitive function, and ability to cooperate in completing sleep-related assessments.

Exclusion criteria

Exclusion criteria: 1.Patients allergic to dexmedetomidine, nasal spray preparations, or any component of anesthetic drugs. 2.(2)Sleep disorders with Pittsburgh Sleep Quality Index (PSQI) > 7 points. 3.(3)Severe hepatic and renal insufficiency (Child-Pugh classification of liver function = Grade C, creatinine clearance rate of renal function < 30 ml/min); severe cardiovascular diseases (such as atrioventricular block, etc.). 4.(4)Patients with nasal diseases (such as severe rhinitis, nasal polyps, nasal deformities, etc.) that affect the absorption of nasal spray drugs. 5.(5)Patients who have used sedative-hypnotics, opioid analgesics, or drugs with obvious sedative effects within 24 hours before surgery; patients who have used the above drugs for a long time and cannot stop taking them before surgery. 6.(6)Patients with sleep apnea syndrome or snoring. 7.(7)Patients with severe cognitive impairment, mental illness, or communication disorders who cannot cooperate with the assessment. 8.(8)Patients who develop severe postoperative complications (such as infection, bleeding, pulmonary embolism, etc.) that affect sleep assessment. 9.(9)Unplanned transfer to the Intensive Care Unit (ICU) after surgery.

Design outcomes

Primary

MeasureTime frame
Richards-Campbell Sleep Questionnaire(PCSQ);

Secondary

MeasureTime frame
Incidence of adverse reactions;Visual Analogue Scale (VAS) pain score;The wearable bracelet recorded total sleep duration, deep sleep duration, the ratio of deep to light sleep, and the number of awakenings;Self-Rating Anxiety Scale;Rescue measures;

Countries

China

Contacts

Public ContactLi Heng

Affiliated Qingyuan Hospital, Guangzhou Medical University (Qingyuan People's Hospital)

aheng@163.com+86 763 3113871

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 30, 2026