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Study on the Use of Low-Dose Esketamine for Preoperative Anti-Anxiety in Patients Undergoing Gynecological Day Surgery

Comparison of Low-Dose Esketamine versus Midazolam for Preoperative Anti-Anxiety Effects in Patients Undergoing Gynecological Day Surgery: A Randomized, Double-Blind, Controlled Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600120977
Enrollment
Unknown
Registered
2026-03-24
Start date
2026-03-26
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Anxiety Disorder (Preoperative)

Interventions

Group M:Preoperative intravenous injection of midazolam
Group E:Preoperative intravenous administration of esketamine

Sponsors

Zhongshan People’s Hospital(Affiliated Zhongshan Hospital of Sun Yat-sen University)
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 44 Years

Inclusion criteria

Inclusion criteria: 1.Females, 18 to 44 years of age; 2.ASA physical status I-II, scheduled for day-case hysteroscopic endometrial lesion resection or loop electrosurgical excision procedure (LEEP); 3.Voluntary participation in this clinical trial and provision of written informed consent; 4.BMI: 18-30 kg/m^2;

Exclusion criteria

Exclusion criteria: 1.Amsterdam Preoperative Anxiety and Information Scale (APAIS) anxiety subscore 100 beats per minute, or history of any other cardiac arrhythmia; 4.Poor comprehension, psychiatric disorders, or central nervous system disturbances that would preclude cooperation; 5.History of severe cardiac, cerebrovascular, respiratory, hepatic, or renal disease; 6.Hypertension, intracranial hypertension, glaucoma, or untreated/poorly controlled hyperthyroidism; 7.Pregnant or lactating women; 8.Perimenopausal or postmenopausal women (defined as: age >= 45 years and amenorrhea for >=12 months); 9.History of alcohol or opioid substance abuse, or chronic use of sedative or anticonvulsant medications; 10.Unwilling to sign the informed consent form.

Design outcomes

Primary

MeasureTime frame
Visual analog scale for anxiety,VAS-A;

Secondary

MeasureTime frame
Numerical Rating Scale, NRS;Total Hospitalization Cost;Total Length of Hospital Stay;Incidence of Perioperative Drug-Related Adverse Events;Athens Insomnia Scale, AIS;Quality of Recovery-15 score,QOR-15;Ramsay Sedation Scale;

Countries

China

Contacts

Public ContactXiaozu Liao

Zhongshan People’s Hospital(Affiliated Zhongshan Hospital of Sun Yat-sen University)

liaoxiaozu@163.com+86 760 89880319

Outcome results

None listed

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