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Effect of remimazolam combined with remifentanil on anesthetic effect and postoperative cognitive function in patients undergoing radical mastectomy for breast cancer

Effect of remimazolam combined with remifentanil on anesthetic effect and postoperative cognitive function in patients undergoing radical mastectomy for breast cancer

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106237
Enrollment
Unknown
Registered
2025-07-21
Start date
2025-07-28
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Breast cancer

Interventions

Etomidate-propofol group:Anesthesia induction: intravenous administration of a 2:3 mixture of etomidate and propofol at 0.2 mL/kg Anesthesia maintenance: intravenous infusion of a 2:3 mixture of etomi
Remimazolam group:Anesthesia induction: intravenous administration of remimazolam besylate 0.3 mg/kg Anesthesia maintenance: intravenous infusion of remimazolam besylate 0.4-1.2 mg/(kg·h)

Sponsors

The First Affiliated Hospital of Anhui University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
60 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with primary breast cancer by pathological diagnosis and undergoing radical mastectomy at a scheduled time, with TNM stage I-II; 2. Age 60-75 years old; 3. ASA grade II-IV; 4. Body mass index (BMI) 22-28 kg/m^2; 5. Participate voluntarily and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with severe cerebrovascular disease, craniocerebral trauma, etc. that affect cognitive function assessment; 2. Patients with a history of mental disorders and taking sedatives, hypnotic drugs and psychotropic drugs in the past six months; 3. Patients with severe heart, lung, liver, kidney and metabolic diseases that cause intolerance to general anesthesia surgery; 4. Patients with allergic reaction to any component of the experimental drug; 5. Patients with adrenal cortex insufficiency; 6. Operation time > 3.5 hours; 7. Blood transfusion during operation; 8. Intraoperative bleeding > 500ml.

Design outcomes

Primary

MeasureTime frame
Postoperative pain;Cognitive function;Postoperative adverse reactions;

Secondary

MeasureTime frame
Intraoperative vital signs;Wake-up quality;

Countries

China

Contacts

Public ContactShi Jun

The First Affiliated Hospital of Anhui University of Science and Technology

sikao1972@163.com+86 181 5549 8918

Outcome results

None listed

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