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A Clinical Controlled Study on Perioperative Sedation with Dexmedetomidine Nasal Spray in Patients with Pudendal Neuralgia Complicated by Anxiety Disorders

A Clinical Controlled Study on Perioperative Sedation with Dexmedetomidine Nasal Spray in Patients with Pudendal Neuralgia Complicated by Anxiety Disorders

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106316
Enrollment
Unknown
Registered
2025-07-22
Start date
2025-08-01
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

pudendal neuralgia,PN

Interventions

Saline Control Group:30 minutes before surgery, the subject was given a corresponding volume of physiological saline through the nose.
Dexmedetomidine Nasal Spray Group:30 minutes before surgery, the subject was given 100ug of dexmedetomidine via nasal route.

Sponsors

Peking University People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 60 years, with no gender restriction; 2. 18.5 kg/m² = 7; 5. Capable of signing the informed consent form;

Exclusion criteria

Exclusion criteria: 1. Allergic to dexmedetomidine; 2. Pain caused by pelvic malignancies or autoimmune diseases; 3. Currently taking anticoagulant medications or having abnormal coagulation function; 4. Pregnancy; 5. Systemic infectious diseases; 6. Unable to complete scale assessments.

Design outcomes

Primary

MeasureTime frame
Perioperative anxiety visual analog scale;

Secondary

MeasureTime frame
Changes in pain associated with pudendal neuralgia;Blood pressure, heart rate, and oxygen saturation;Ramsay Sedation Scale;Patient Global Impression of Change;Adverse drug reactions;The degree of pain during surgical puncture;Changes in anxiety traits;

Countries

China

Contacts

Public ContactLiu Yiming

Peking University People's Hospital

liuyiming1984@163.com+86 10 88325206

Outcome results

None listed

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