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Clinical observation of different doses of dexmedetomidine nasal spray for preoperative anxiety in patients with intraspinal anesthesia

Clinical observation of different doses of dexmedetomidine nasal spray for preoperative anxiety in patients with intraspinal anesthesia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107195
Enrollment
Unknown
Registered
2025-08-06
Start date
2025-08-10
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Preoperative anxiety

Interventions

50µg group:Vital signs of the patients were monitored the night before surgery, and 50µg dexmedetomidine nasal spray was administered for anti-anxiety and sedation without oxygen inhalation.
75µg group:Vital signs of the patients were monitored the night before surgery, and 75µg dexmedetomidine nasal spray was administered for anti-anxiety and sedation without oxygen inhalation.
100µg group:Vital signs of the patients were monitored the night before surgery, and 100µg dexmedetomidine nasal spray was administered for anti-anxiety and sedation without oxygen inhalation.

Sponsors

Wuhan Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Adult patients undergoing elective rectal mucosal resection under spinal anesthesia were less than 60 years old, ASA1-2 grade, Hamilton Anxiety Scale (HAMA) >=7 points, insomnia severity index (ISI) >7 points.

Exclusion criteria

Exclusion criteria: Severe cardiovascular, respiratory system, liver and kidney function, coagulation function abnormalities; Severe sinus bradycardia (heart rate <=50 beats/min) and second degree or more atrioventricular block; Preoperative cognitive dysfunction; Long-term use of sedatives or sleeping pills; Patients judged to have difficulty managing the respiratory tract: modified Markov score level III and above.

Design outcomes

Primary

MeasureTime frame
Ramsay score;total sleep duration; ISI scale score ; preoperative sleep satisfaction score ;

Secondary

MeasureTime frame
Vital signs at different points in time;Satisfaction score of medical staff with this drug;

Countries

China

Contacts

Public ContactGuangjun Hu

Wuhan Third Hospital

jeanhu@163.com+86 189 0713 2861

Outcome results

None listed

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