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Effects of Esketamine Combined with Sufentanil for Postoperative Analgesia on Postoperative Anxiety and Depression in Breast Cancer Patients with Preoperative Anxiety:a single-center, double blind, prospective, randomized controlled, clinical study

Effects of Esketamine Combined with Sufentanil for Postoperative Analgesia on Postoperative Anxiety and Depression in Breast Cancer Patients with Preoperative Anxiety

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102614
Enrollment
Unknown
Registered
2025-05-16
Start date
2025-01-19
Completion date
Unknown
Last updated
2025-05-19

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

Conditions

Anxiety and Depression

Interventions

Test group H:1.0ug/kg Sufentanil +0.5mg/kg esketamine +5mg tropisetron +2ug/kg dexmetopidine was prepared into 100ml with sodium chloride and added to the postoperative analgesic pump
Test group L:1.0ug/kg Sufentanil +0.3mg/kg esketamine +5mg tropisetron +2ug/kg dexmetopidine was prepared into 100ml with sodium chloride and added to the postoperative analgesic pump
Control group:2.0ug/kg Sufentanil +5mg tropisetron +2ug/kg dexmetopil was prepared into 100ml with sodium chloride and added to the postoperative analgesic pump

Sponsors

Tangdu Hospital, Air Force Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients scheduled for radical mastectomy under general anesthesia; 2. Age >= 18 years and < 65 years; BMI index 18 - 30 kg/m²; 3. ASA grade I to III; 4. Primary tumor, without radiotherapy or chemotherapy before surgery; 5. Voluntary signing of informed consent; 6. Preoperative SAS score greater than 50 points.

Exclusion criteria

Exclusion criteria: 1. A history of depression or other mental disorders before the operation; 2. Poor comprehension or communication barriers, unable to cooperate with the researcher; 3. Severe heart disease (cardiac function grade III or above); 4. Preoperative visit blood pressure >= 180/110 mm Hg (WHO-ISH grade 3 hypertension); 5. History of breast surgery; 6. Participants who have taken part in other clinical trials within the three months prior to being included in this study; 7. Other conditions deemed unsuitable for participation in this study by the attending physician or researcher (reasons must be recorded).

Design outcomes

Primary

MeasureTime frame
Postoperative depression self-rating scale score;

Secondary

MeasureTime frame
Postoperative anxiety self-rating scale score;Postoperative nausea and vomiting score;Postoperative pain score;Serum tumor necrosis factor a(TNF-a) and interleukin-6 (IL-6) levels before and after surgery;Number of postoperative analgesic pump compressions;

Countries

China

Contacts

Public ContactChangjun Gao

Tangdu Hospital, Air Force Military Medical University

gaocj74@163.com+86 29 8477 7439

Outcome results

None listed

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