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Observation on the Efficacy of Nasal Spray of Dexmedetomidine in Managing Anxiety and Sleep during the Perioperative Period of Hip and Knee Arthroscopy

Clinical Research of the Observation on the Efficacy of Nasal Spray of Dexmedetomidine in Managing Anxiety and Sleep during the Perioperative Period of Hip and Knee Arthroscopy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500112776
Enrollment
Unknown
Registered
2025-11-19
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-11-24

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

Conditions

Perioperative anxiety and sleep disorders in hip and knee arthroscopic surgeries

Interventions

experimental group:Preoperative routine anxiety reduction intervention + nasal spray of dexmedetomidine (100 µg per dose) group
control group:Preoperative routine anxiety reduction intervention + nasal spray of normal saline group

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged between 18 and 50 years old who are scheduled for elective surgeries; 2. Intending to undergo hip arthroscopy or knee arthroscopy; 3. ASA classification I-II; 4. Having a certain degree of preoperative anxiety (preoperative STAI-S score >= 40 points); 5. The surgery is planned to be performed under general anesthesia; 6. Agreeing to receive nasal spray intervention, and having no drug contraindications; 7. Signing the informed consent form, understanding the research purpose and process, and willing to follow the research protocol and follow-up arrangements.

Exclusion criteria

Exclusion criteria: 1. Those who are allergic to dexmedetomidine or its excipient components; 2. Those with significant nasal diseases or nasal obstruction (such as nasal polyps, severe nasal septum deviation, chronic rhinitis, etc.) that affect drug absorption; 3. Those with moderate to severe cardiovascular diseases (such as second-degree or higher atrioventricular block, bradycardia < 50 bpm, uncontrolled hypertension or hypotension); 4. Those with severe liver or kidney dysfunction; 5. Those with active mental disorders, severe depression or receiving psychiatric medication treatment; 6. Those with diagnosed sleep disorders or undergoing intervention (such as using melatonin, sedative-hypnotic drugs); 7. Those who used drugs that may affect anxiety levels within 7 days before the surgery (such as benzodiazepines, antidepressants, etc.); 8. Those who cannot cooperate in filling out the scale or undergoing postoperative follow-up (such as having language disorders, difficulty in reading, etc.); 9. Those with a history of hip and knee arthroscopy or other major joint surgeries in the past, which may affect the psychological baseline state.

Design outcomes

Primary

MeasureTime frame
State-Trait Anxiety Inventory,STAI-Form Y;

Secondary

MeasureTime frame
Amsterdam preoperative anxiety and information scale,APAIS;Generalized Anxiety Disorder,GAD-7;Pittsburgh Sleep Quality Index,PSQI;Leeds Sleep Evaluation Questionnaire,LSEQ;Visual Analog Scal,VAS;

Countries

China

Contacts

Public ContactChen Gang

West China Hospital, Sichuan University

chengang_sportsmed@163.com+86 189 8060 6707

Outcome results

None listed

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