Skip to content

The effect of Esketamine on post-traumatic stress disorder in breast cancer surgery patients: A randomized ,controlled clinical trial

The effect of Esketamine on post-traumatic stress disorder in breast cancer surgery patients: A randomized ,controlled clinical trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500098866
Enrollment
Unknown
Registered
2025-03-14
Start date
2025-04-15
Completion date
Unknown
Last updated
2025-08-25

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

Conditions

Post-traumatic stress disorder

Interventions

Experimental group:After the patient entered the room and improved vital monitoring, intravenous infusion was given slowly at 0.2mg/kg esketamine for 10mins during anesthesia induction and continued a
control group:After the patient entered the room and improved vital monitoring, under PSI monitoring, 0.9% normal saline was slowly injected intravenously at 0.2mg/kg for 10mins during anesthesia indu

Sponsors

The First Affiliated Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Obtain informed consent; 2. Age >=18 years, <=60 years; 3. Patients undergoing mastectomy under general anesthesia; 4. American Society of Anesthesiologists (ASA) Grade I to III

Exclusion criteria

Exclusion criteria: 1. Severe heart, lung, liver and kidney dysfunction; 2. Have a history of mental illness or long-term psychiatric drugs (dementia, schizophrenia), chronic analgesic drug use history, alcohol abuse history; 3. Any cerebrovascular accident occurred within 3 months, such as stroke, transient ischemic attack (TIA), etc. 4. Previous history of major physical trauma; 5. Patients who are allergic to the experimental drug or have other nerve block contraindications; 6. Severe visual, hearing or speech impairment, inability to complete psychological and cognitive tests; 7. Participated in another drug clinical study within the past 30 days.

Design outcomes

Primary

MeasureTime frame
Incidence of post-traumatic stress disorder 30 days after surgery;

Secondary

MeasureTime frame
Patient EEG analysis using patient status Index (PSI) monitoring (including the proportion of various waveforms, etc.);Postoperative sleep quality score;Incidence and severity of postoperative delirium;Incidence and severity of postoperative depression;The incidence and severity of postoperative anxiety;Dosage of analgesic drugs;Postoperative hospital stay;postoperative complications;90-day postoperative mortality;Resting and exercise pain scores;Incidence of post-traumatic stress disorder 30 days after surgery;Incidence of post-traumatic stress disorder 30 days after surgery;

Countries

China

Contacts

Public ContactQiu Gaolin

The First Affiliated Hospital of Anhui Medical University

1615423688@qq.com+86 181 1960 0391

Outcome results

None listed

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