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Effects of Intravenous Esketamine on Sleep Disorders in Female Patients with Sleep Disturbances Following Hysteroscopic Surgery: A Randomized, Double-Blind, Controlled Trial

Effects of Intravenous Esketamine on Sleep Disorders in Female Patients with Sleep Disturbances Following Hysteroscopic Surgery: A Randomized, Double-Blind, Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600127717
Enrollment
Unknown
Registered
2026-07-06
Start date
2026-07-10
Completion date
Unknown
Last updated
2026-07-13

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

Conditions

sleep disorders

Interventions

Esketamine Group:Intravenous injection of 0.2 mg/kg esketamine during operation
Normal Saline Placebo Group:Intravenous saline during surgery

Sponsors

Zhejiang Xiaoshan Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Preoperative sleep disorder is defined as a Pittsburgh Sleep Quality Index (PSQI) total score > 5. 2. Age 18-65 years, female. 3. American Society of Anesthesiologists (ASA) classification I-II. 4. Planned elective hysteroscopic surgery under intravenous general anesthesia (such as endometrial polyp removal, intrauterine adhesion separation, submucosal fibroid removal, etc.). 5. Voluntarily participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Contraindications or allergies to esketamine, ketamine, general anesthetics, opioids, or non-steroidal drugs; 2. History of mental illness, cognitive impairment, or inability to cooperate with questionnaire completion; 3. Severe cardio-cerebrovascular diseases (uncontrolled hypertension, unstable angina pectoris, severe arrhythmia), hepatic and renal insufficiency (Child-Pugh class C, CrCl 3 months) regular use of sedative-hypnotics, antidepressants, or opioids preoperatively; 6. Pregnant or lactating women; 7. Expected operative time exceeding 1 hour, or major unexpected intraoperative changes such as conversion to laparotomy.

Design outcomes

Primary

MeasureTime frame
Incidence of sleep disturbance after hysteroscopy;

Secondary

MeasureTime frame
sleep quality;pain intensity;consumption of analgesics;

Countries

China

Contacts

Public ContactHua Xing

Zhejiang Xiaoshan Hospital

2269964361@qq.com+86 571 8386 5858

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026