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A clinical study on the effect of sub-anesthetic dose of esketamine in alleviating anxiety in patients with vulvar leukoplakia treated by focused ultrasound

A clinical study on the effect of sub-anesthetic dose of esketamine in alleviating anxiety in patients with vulvar leukoplakia treated by focused ultrasound

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600124704
Enrollment
Unknown
Registered
2026-05-15
Start date
2026-01-23
Completion date
Unknown
Last updated
2026-05-18

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

Conditions

Perioperative anxiety

Interventions

Esketamine group(E):At the beginning of the anesthesia induction, eszopiclone was intravenously infused (0.5 mg/kg, diluted to 20 mL, with a pumping time of 20 minutes)
Control group(C):Intravenous infusion of an equal volume (over 20 minutes) of normal saline

Sponsors

Affiliated Hospital of North Sichuan Medical College
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Patients diagnosed with vulvar leukoplakia and scheduled for focused ultrasound treatment; 2.aged between 18 and 65 years; 3.with ASA classification of I-III; 4.and who have signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Those with contraindications or allergies to esketamine or other study drugs; 2.those with preoperative mental disorders (such as moderate to severe depression, obsessive-compulsive disorder, etc.) or cognitive impairments; 3. those with severe liver or kidney dysfunction; 4.pregnant women or lactating women, and those who cannot cooperate.

Design outcomes

Primary

MeasureTime frame
Hamilton Anxiety Scale (HAMA) scores at 1, 3, 7 and 30 days after surgery;

Secondary

MeasureTime frame
Anxiety levels at 1, 3, 7 and 30 days after surgery;Depression levels at 1, 3, 7 and 30 days after surgery;Pain levels at 1, 3, 7 and 30 days after the operation;Postoperative recovery quality at 1, 3, 7 and 30 days;Sleep quality 30 days after surgery;The levels of plasma BDNF, cortisol and IL-6 within 24 hours after the operation;Vital signs;Dosage of anesthetic drugs;Anesthesia Surgery Information;Incidence of adverse events;

Countries

China

Contacts

Public ContactQilin Liu

Affiliated Hospital of North Sichuan Medical College

574647439@qq.com+86 191 1424 0775

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 22, 2026