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Dexmedetomidine hydrochloride nasal spray for improving perioperative anxiety in elderly orthopedic trauma patients: a randomized controlled trial

Dexmedetomidine hydrochloride nasal spray for improving perioperative anxiety in elderly orthopedic trauma patients: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600121861
Enrollment
Unknown
Registered
2026-04-06
Start date
2026-04-06
Completion date
Unknown
Last updated
2026-04-14

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

Conditions

Perioperative anxiety

Interventions

Intervention group A:A single nasal spray of dexmedetomidine hydrochloride (dose 1.0µg/kg) 1 h prior to surgery
Intervention group B:A single nasal spray of dexmedetomidine hydrochloride (dose 1.5µg/kg) 1 h prior to surgery
Control group:At the same time point, an equal volume of saline nasal spray (placebo) was administered

Sponsors

Jingzhou Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age: >= 65 years old; 2. Disease diagnosis: Acute orthopedic trauma requiring surgical treatment (such as hip fractures, spinal fractures, limb fractures); 3. Preoperative anxiety: Confirmed by standardized assessment (STAI-S score >= 40 points); 4. ASA classification: I-III grade, capable of withstanding anesthesia and surgery; 5. Informed consent: The patient or legal representative signs a written informed consent form; 6. Nasal condition: No severe nasal anatomical abnormalities or acute inflammation (ensure nasal spray administration is feasible)

Exclusion criteria

Exclusion criteria: 1. Cognitive or communication disorders: such as dementia, mental illness or language impairment, making it impossible to cooperate with the assessment; 2. Drug-related contraindications: 3. History of allergy to dexmedetomidine; 4. Recent (within 72 hours) use of sedative/anxiolytic drugs (such as benzodiazepines, opioids); 5. Severe comorbidities: Uncontrolled cardiovascular diseases (such as heart rate < 50 beats per minute, systolic blood pressure < 90 mmHg); Liver and kidney dysfunction (Child-Pugh C grade or eGFR < 30 mL/min); Severe respiratory diseases (requiring mechanical ventilation or oxygen dependence); 6. Other exclusion factors: Emergency surgery (requiring immediate intervention and unable to complete the preoperative medication process); Intra-spinal anesthesia contraindications (infection at the puncture site, intracranial hypertension or severe heart and lung diseases); Long-term use of a2 receptor agonists or antagonists (such as clonidine, mivacurium);

Design outcomes

Primary

MeasureTime frame
Anxiety score (STAI-S) 24h after surgery;

Secondary

MeasureTime frame
hemodynamic stability;Anxiety dynamics;Security;Recovery quality;Pain control;

Countries

China

Contacts

Public ContactZhang Kun

Jingzhou Central Hospital

zhangkunyangtzeu@163.com+86 716 849 8194

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026