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The Effect of Dexmedetomidine Nasal Spray Before Knee arthroscopy debridement on Postoperative Sleep Disorders: A Prospective, Randomized, Controlled Trial

The Effect of Dexmedetomidine Nasal Spray Before Knee arthroscopy debridement on Postoperative Sleep Disorders: A Prospective, Randomized, Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600126468
Enrollment
Unknown
Registered
2026-06-09
Start date
2026-06-15
Completion date
Unknown
Last updated
2026-06-15

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

Conditions

Sleep disorder

Interventions

Group B:Preoperative nasal spray of normal saline
Group A:Preoperative nasal spray of dexmedetomidine

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Ages 18 and older; 2.ASA I-III level; 3.Patients undergoing elective knee arthroscopy debridement; 4.Patients with preoperative sleep disorders(PSQI>5);

Exclusion criteria

Exclusion criteria: 1.Patients who refuse to provide informed consent form and refuse postoperative follow-up (including telephone follow-up after discharge); 2.Patients with contraindications or allergies to dexmedetomidine, general anesthetics, opioid drugs, or nonsteroidal drugs; 3.BMI below 19 or above 30 kg/m²; 4.Patient's medical history, such as preoperative heart rate less than 50 beats per minute; Sick sinus syndrome; Second degree or higher atrioventricular block; Left ventricular ejection fraction<50%; Individuals with previous obstructive sleep apnea syndrome; History of neurological, psychiatric, or mental health disorders; 5.Participants have participated in clinical trials of other drugs within the past 4 weeks; 6.Any situation that the researcher deems unsuitable for inclusion for any reason;

Design outcomes

Primary

MeasureTime frame
The incidence of sleep disorders on the first night after surgery;

Secondary

MeasureTime frame
The incidence of sleep disorders on the 2nd, 3rd, and 7th night after surgery;Postoperative nausea and vomiting incidence rate;Postoperative delirium incidence (0-24 hours);Anxiety and depression scores on postoperative days 1, 2, 3, and 7;Pain scores at rest and after activity 1 hour after surgery and on postoperative days 1, 2, 3, and 7;

Countries

China

Contacts

Public ContactLuo Mengqiang

Huashan Hospital, Fudan University

luomq16@fudan.edu.cn+86 21 52887694

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 21, 2026