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Effects of Remimazolam Tosilate on postoperative emotional state in patients with breast cancer

Effects of Remimazolam Tosilate on postoperative emotional state in patients with breast cancer

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300069093
Enrollment
Unknown
Registered
2023-03-07
Start date
2023-03-07
Completion date
Unknown
Last updated
2023-05-22

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

Conditions

breast cancer

Interventions

Control Group:No
Remimazolam :R1 Group:Maintenance of anesthesia:Propofol+Remimazolam 0.1mg/kg/h
Remimazolam :R1 Group :Maintenance of anesthesia:Propofol+Remimazolam 0.3mg/kg/h

Sponsors

Department of Anesthesia, the first People's Hospital of Lianyungang
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1)18= age < 65 years; 2)Selective radical operation for breast cancer, the operation time was less than 3 hours; 3)ASA :I-II; 4)18kg/m2 < BMI < 30kg/m2; 5)Patients have a clear understanding of the study and voluntarily participate in the study and have their informed consent .

Exclusion criteria

Exclusion criteria: 1) Patients who had severe anxiety and depression before operation, or who had been diagnosed with mental system disease and had a long-term history of taking psychotropic drugs; 2) Radical operation for bilateral breast cancer; 3) Patients with severe cardiac cerebrovascular disease, liver and renal dysfunction before operation; High-dose or long-term use of benzodiazepine, alcohol or sedatives within a week; 5) Having a history of epilepsy or a family history of epilepsy; 6) Allergic or contraindicated to any drug in the test; 7) Those who could not cooperate with the MMSE test before operation and whose scores were lower than their corresponding educational level (illiteracy =17 points, primary school =20 points, middle school =22 points, university =23 points) ; 8) Other conditions in which the researchers considered it inappropriate to participate in the study.

Design outcomes

Primary

MeasureTime frame
HADS scores of the first postoperative day;

Secondary

MeasureTime frame
HADS scores of before surgery and the first to three postoperative days;VAS and AIS scores of before surgery and the first to three postoperative days;HR, MBP, SPO2, BIS at baseline, intubation, skin incision, mastectomy, skin suture and extubation;The amount of vasoactive drugs used during operation;Incidence of clinical adverse events;Postoperative patient satisfaction scores;

Countries

China

Contacts

Public ContactYong Wu

Nanjing Medical University, Department of Anesthesiology, Lianyungang School of Clinical Medicine

18961325621@163.com18961325621

Outcome results

None listed

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