Effect of Neoadjuvant Chemotherapy on Cardiac Function of Perioperative Patients With Breast Cancer and New Strategies for Anesthesia

NCT06497660 | Recruiting Phase 4

• 1 other identifier: LZMLRJXFZHLRXAYJ
• Study Type: interventional
• Target: 496
• Locations: 1 country
• Sites: 1

Brief Summary

As is well known, perioperative hemodynamic fluctuations, such as decreased blood pressure and heart rate, and cardiac dysfunction, are common complications after anesthesia. General anesthetics such as propofol and sufentanil can inhibit the central nervous system, reduce cardiac excitability and myocardial contractility, dilate peripheral blood vessels, and have a high incidence of hypotension, especially during anesthesia induction, which is particularly common in the elderly and those with underlying underlying diseases before surgery. However, the current research on the impact of neoadjuvant chemotherapy on perioperative cardiac function in patients is not specific, and there is no unified anesthesia strategy for these effects during the perioperative period. Therefore, this study aims to explore: 1. the effect of neoadjuvant chemotherapy on perioperative cardiac function in patients; 2. Improve the anesthesia plan and further explore new strategies for perioperative organ protection for such patients. The research design is a prospective, randomized, controlled trial.

Conditions

Breast Cancer; Neoadjuvant Chemotherapy; Perioperative Period; Anaesthesia; Cardiac Function

Outcome Measures

Primary Outcomes (1)

• The degree of blood pressure decrease during anesthesia induction

  Compare the blood pressure changes of patients after entering the operating room and undergoing anesthesia induced tracheal intubation.（Unit in mmHg）

  On the day of surgery, compare the blood pressure changes of patients after entering the operating room and anesthesia induced tracheal intubation, with a maximum of 12 months after surgery.

Study Arms (8)

A α group

EXPERIMENTAL

Breast cancer patients with neoadjuvant chemotherapy scheme of "EC-T" and selective surgery were selected, and they were intervened with norepinephrine during the perioperative period.

Drug: Deoxyadrenaline

B α group

EXPERIMENTAL

Breast cancer patients with "TCb" neoadjuvant chemotherapy and elective surgery were selected, and they were intervened with norepinephrine during the perioperative period

Drug: Deoxyadrenaline

C α group

EXPERIMENTAL

Breast cancer patients with "TCbHP" neoadjuvant chemotherapy and elective surgery were selected, and they were intervened with norepinephrine during the perioperative period.

Drug: Deoxyadrenaline

control α group

PLACEBO COMPARATOR

Patients with breast cancer who have not received neoadjuvant chemotherapy and who have undergone elective surgery, and who have received perioperative intervention with norepinephrine.

Drug: Deoxyadrenaline

A β group

EXPERIMENTAL

Select breast cancer patients with neoadjuvant chemotherapy scheme of "EC-T" and elective surgery, and use normal saline for control during perioperative period.

Drug: normal saline

B β group

EXPERIMENTAL

Breast cancer patients with "TCb" neoadjuvant chemotherapy and elective surgery were selected, and physiological saline was used as control during perioperative period.

Drug: normal saline

C β group

EXPERIMENTAL

Breast cancer patients with "TCbHP" neoadjuvant chemotherapy and elective surgery were selected, and physiological saline was used as control during perioperative period.

Drug: normal saline

control β group

PLACEBO COMPARATOR

Breast cancer patients who have not received neoadjuvant chemotherapy and who have undergone elective surgery, and who use normal saline control during the perioperative period.

Drug: normal saline

Interventions

Deoxyadrenaline DRUG

Deoxyadrenaline is a vasoactive drug

A α group; B α group; C α group; control α group

normal saline DRUG

Deoxyadrenaline is a vasoactive drug

A β group; B β group; C β group; control β group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 and above;
• Left ventricular ejection fraction shall not be less than 45% before neoadjuvant chemotherapy and not less than 40% after neoadjuvant chemotherapy;
• The electrocardiogram shows sinus rhythm;
• Acetylsalicylic acidlevel I to III;
• Can understand and cooperate with the research process.

You may not qualify if:

• Patients with congenital organic heart disease, arrhythmia requiring intervention, heart valve disease, cardiomyopathy, high atrioventricular and bundle branch block, history of myocardial infarction, severe hypertension, long-term diabetes and other diseases affecting heart function;
• Patients with severe dysfunction of important organs such as liver and kidney, who are intolerant to neoadjuvant chemotherapy or surgical anesthesia;
• Patients who are allergic to the drugs used in this study;
• Patients with mental illness, consciousness disorders, and communication barriers;
• Patients with severe coagulation dysfunction;
• Patients who have used monoamine oxidase inhibitors within two weeks prior to anesthesia surgery;
• Patients who refused to participate in this study.

Sponsors & Collaborators

• Fujian Medical University Union Hospital: lead

Study Sites (1)

Fujian Medical University Affiliated Union Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Deoxyepinephrine; Saline Solution

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dopamine; Catecholamines; Amines; Organic Chemicals; Epinephrine; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Zhongmeng LZM Lai, Doctor of Medicine

CONTACT

13395000771; angerer1980@163.com

Rongjian LRJ Li, Bachelor of Medicine

CONTACT

13328595626; 1216254452@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2024
• First Posted: July 12, 2024
• Study Start: August 1, 2024
• Primary Completion: August 2, 2025
• Study Completion: December 31, 2025
• Last Updated: March 4, 2025

Record last verified: 2024-03

Locations

CN (1)