Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-01-07 @ 3:55 AM
Study NCT ID:
NCT06497660
Status:
RECRUITING
Last Update Posted:
2025-03-04
First Post:
2024-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Neoadjuvant Chemotherapy on Cardiac Function of Perioperative Patients With Breast Cancer and New Strategies for Anesthesia
Sponsor:
Fujian Medical University Union Hospital
Organization:
Study Overview
Official Title:
Effect of Neoadjuvant Chemotherapy on Cardiac Function of Perioperative Patients With Breast Cancer and New Strategies for Anesthesia Response: a Multicenter, Prospective, Randomized, Controlled Study
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
Traditional chemotherapy is a common treatment for cancer, usually performed after surgery, with the aim of assisting in the removal of remaining cancer cells. Nausea, vomiting, fatigue, hair loss, bone marrow suppression, and other common complications can even affect the function of important organs such as the heart, lungs, and brain. In the 1980s, with the reflection on traditional chemotherapy and further understanding of tumor biology, clinical trials and research began to focus on a method of neoadjuvant chemotherapy that combines surgical resection before surgery.
Neoadjuvant chemotherapy refers to the systemic chemotherapy performed before implementing local treatment methods (such as surgery), with the aim of reducing the size of the tumor, killing invisible metastatic cells early, and reducing adverse reactions to traditional chemotherapy \[6\], which is a new chemotherapy method that is beneficial for subsequent surgery, radiotherapy, and other treatments. However, it should be noted that neoadjuvant chemotherapy may still cause a certain degree of cardiac dysfunction.
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.
In summary, after completing neoadjuvant chemotherapy, the patient\'s physical and mental functions are affected to a certain extent. If combined with the effects of anesthetic drugs, the hemodynamic fluctuations are greater than those of the general population, which may further cause cardiac dysfunction and is worthy of attention. 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.
Neoadjuvant chemotherapy refers to the systemic chemotherapy performed before implementing local treatment methods (such as surgery), with the aim of reducing the size of the tumor, killing invisible metastatic cells early, and reducing adverse reactions to traditional chemotherapy \[6\], which is a new chemotherapy method that is beneficial for subsequent surgery, radiotherapy, and other treatments. However, it should be noted that neoadjuvant chemotherapy may still cause a certain degree of cardiac dysfunction.
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.
In summary, after completing neoadjuvant chemotherapy, the patient\'s physical and mental functions are affected to a certain extent. If combined with the effects of anesthetic drugs, the hemodynamic fluctuations are greater than those of the general population, which may further cause cardiac dysfunction and is worthy of attention. 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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: