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The perioperative effects and efficacy evaluation of dexmedetomidine nasal spray in gynecological patients with anxiety: A randomized, double-blind controlled study

The perioperative effects and efficacy evaluation of dexmedetomidine nasal spray in gynecological patients with anxiety: A randomized, double-blind controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109960
Enrollment
Unknown
Registered
2025-09-28
Start date
2025-10-15
Completion date
Unknown
Last updated
2025-10-06

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

Conditions

Preoperative anxiety

Interventions

:Treatment of anxiety with 2 sprays of dexmedetomidine nasal spray (total 50 µg)
Normal saline nasal spray control group (Group C):Two sprays of normal saline nasal spray for the treatment of anxiety (placebo effect)

Sponsors

Weifang People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients with American Society of Anesthesiologists (ASA) physical status class I to III (I for healthy,II for mild systemic disease,III for severe systemic disease); 2. Between 18 and 65 years old; 3. Preoperative anxiety (HAMA anxiety scale score >=14); 4. Uterine surgery (hysterectomy, myomectomy)

Exclusion criteria

Exclusion criteria: 1. The patient refused to participate in the study; 2. History of allergy to dexmedetomidine or other a2 adrenergic receptor agonists; 3. Diagnosis or suspicion of sleep apnea; 4. History of alcohol dependence or drug abuse (especially sedatives, hypnotics, opioids, etc.); 5. suffering from mental or neurological disorders; 6. Severe bradycardia; 7. Patients with second-degree type ? and third-degree conduction block; 8. Abnormal nasal anatomy or inflammation/infection of nasal cavity and paranasal sinuses.

Design outcomes

Primary

MeasureTime frame
Visual Anxiety Scale score;

Secondary

MeasureTime frame
The incidence of adverse reactions after drug use;Incidence of postoperative agitation in two groups of patients;Intraoperative consumption of propofol and remifentanil;The amount of etomidate consumed when the patient's consciousness disappears during anesthesia induction.;Athens Insomnia Scale score;Intraoperative hemodynamic indicators: mean arterial pressure, heart rate, and bispectral index of electroencephalogram;The number of additional administrations of vasoactive drugs;

Countries

China

Contacts

Public ContactBao Lang

Weifang People's Hospital

wfrmyy91@163.com+86 135 1540 0823

Outcome results

None listed

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