Breast Cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: This study enrolled 120 patients with breast cancer who were scheduled to undergo general anesthesia surgery at the Tianjin Medical Center Cancer Hospital, regardless of gender, aged 40 - 65 years, with ASA I - III, and a BMI of 18 - 25kg/m^2. All patients had normal cardiac ultrasound results (EF>50%) and no severe liver or kidney dysfunction. Patients with clinically relevant dyspnea, resting dyspnea, or orthopnea were required to undergo preoperative tracheal intervention. Those with massive hemoptysis, significant arrhythmias, or coronary artery disease (or suspected of having coronary heart disease or other high - risk diseases) were required to undergo preoperative coronary CTA or coronary angiography. If needed, coronary angiography and intervention were performed before surgery.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: Patients with allergies to eggs or soybeans, severe mental illness, a history of long - term drug abuse, potential difficult airways, pregnancy or breastfeeding, symptomatic neurological diseases, persistent arrhythmias, left ventricular ejection fraction below 40%, moderate or severe valvular heart disease, pulmonary artery pressure exceeding 40mmHg, peripheral vascular diseases (e.g., arterial occlusion), a history of chronic obstructive pulmonary disease, asthma, or pulmonary bullae, renal insufficiency, acute heart or respiratory failure, emergency surgery, or refusal to sign the informed consent form were excluded from the study. Discontinuation Criteria: Patients or their legal representatives could request to withdraw from the study. If patients experienced serious adverse reactions during the study, such as anaphylactic shock, severe respiratory depression, or arrhythmias, which might endanger their life or health, they would be withdrawn. The study would also be terminated if patients developed severe complications like myocardial infarction, respiratory failure, or severe infections. If anesthesia induction failed despite the study drug administration, or if key data was missing due to non - cooperation, loss to follow - up, or other reasons, making effective data analysis impossible, patients would be withdrawn. Patients diagnosed with other serious diseases during the study, which might affect the study results or their treatment plan, would also be excluded. The study would be paused or terminated for ethical issues, such as violation of patient rights or non - compliance with ethical requirements. If the study was prematurely terminated due to other reasons (e.g., funding issues or design flaws), patients would stop participating. Patients who couldn't tolerate the adverse reactions of Lianprocaine disodium even after dose adjustment would also discontinue the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The sedation success rate 5 minutes after the initial administration (the proportion of patients with a MOAA/S score =1 within 5 minutes of drug administration); | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to successful sedation;Time to loss of consciousness;Paresthesia-related indicators;Depth of anesthesia;Hemodynamic parameters;Adverse events;immunomodulation; | — |
Countries
China
Contacts
Tianjin Cancer Hospital Airport Hospital