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Effect of perioperative administration of S(+)-ketamine on anxiety and depression in patients undergoing radical mastectomy

Effect of perioperative administration of S(+)-ketamine on anxiety and depression in patients undergoing radical mastectomy

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050075
Enrollment
Unknown
Registered
2021-08-16
Start date
2021-09-01
Completion date
Unknown
Last updated
2022-04-25

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

Conditions

Breast cancer

Interventions

Group K25:0.25mg/kg D-ketamine
Group K50:0.5mg/kg D-ketamine

Sponsors

The Third Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients and their legal representatives voluntarily participate in the research and sign the informed consent; 2. Patients who underwent radical mastectomy in our hospital: (1) total mastectomy; (2) mastectomy + axillary lymph node dissection; (3) radical mastectomy + breast reconstruction; 3. American Society of Anesthesiologists (ASA) classification I-II, aged 18-70 years, BMI 18-30 kg/m^2; 4. Have not participated in clinical trials of other drugs within 3 months before screening.

Exclusion criteria

Exclusion criteria: 1. Patients who are allergic to dex-ketamine or any of the ingredients or excipients of this preparation; 2. Combination of other vital organ dysfunctions: including severe liver and kidney dysfunction; organic brain diseases, specifically aneurysmal vascular disease or arteriovenous malformation and cerebral hemorrhage; severe hypertension, coronary heart disease, cardiac insufficiency (NYHA >= grade III), pulmonary hypertension; blood system diseases; abnormal coagulation function; severe respiratory system diseases; 3. Patients with preoperative behavior disorder or combined mental illness who have used psychotropic drugs; 4. Have a history of abuse of illegal drugs such as ecstasy and ketamine; 5. Those with a history of alcohol or drug dependence; 6. Chemotherapy has been performed before surgery; 7. Patients deemed unsuitable for inclusion by other investigators.

Design outcomes

Primary

MeasureTime frame
Postoperative patient depression SDS rating;

Secondary

MeasureTime frame
Self-rating anxiety scale (SAS scale) score.;Changes of blood pressure, heart rate, blood oxygen saturation, and airway pressure in perioperative patients;5-year recurrence-free survival;5-year overall survival after surgery;Adverse reactions;

Countries

China

Contacts

Public ContactHei Ziqing

The Third Affiliated Hospital of Sun Yat-sen University

heiziqing@sina.com+86 13925020330

Outcome results

None listed

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