Back to resultsEffect of Intravenous Infusion of Lidocaine on Patients Undergoing Radical Resection of Colorectal Tumors
Primary Purpose
Colorectal Tumors, Lidocaine
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Administer 1.5 mg/kg intravenously to the patient before induction of anesthesia, and continue to infuse 1.5 mg/kg/h during the operation until the end of the operation
Sponsored by
About this trial
This is an interventional other trial for Colorectal Tumors focused on measuring Radical resection of colorectal tumor, lidocaine, stress, immunity, vascular tumor regeneration, inflammation, micrometastasis
Eligibility Criteria
Inclusion Criteria:
- colorectal tumor patients
Exclusion Criteria:
- Weight <45kg and >100kg
- Sensitivity or hypersensitivity to lidocaine
- Second or third degree heart block
- Severe heart failure (ejection fraction < 20%)
- History of active rhythm disorder
- Acute severe liver and kidney injury
- History of uncontrolled seizures
- History of acute porphyria.
Sites / Locations
- Affiliated Hospital of Nantong University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lidocaine is used in radical resection of colorectal tumors.
Arm Description
Administer 1.5 mg/kg intravenously to the patient before induction of anesthesia, and continue to infuse 1.5 mg/kg/h during the operation until the end of the operation
Outcomes
Primary Outcome Measures
the concentration of tumor micrometastasis markers were determined by ELISA
the concentration of tumor micrometastasis markers such as CK20 was determined by ELISA
Secondary Outcome Measures
the concentration of stress hormones were determined by ELISA
the concentration of EPI and NE were determined by ELISA
the concentration of inflammatory factor were determined by ELISA
the concentration of IL-6,IL-8,TNF-α were determined by ELISA
the concentration of angiogenesis factors were determined by ELISA
the concentration of VEGF was determined by ELISA
the concentration of immune indexes were determined by ELISA
the concentration of B lymphocytes, T lymphocytes, NK cells, macrophages were determined by ELISA
Full Information
NCT ID
NCT05484687
First Posted
July 27, 2022
Last Updated
July 31, 2023
Sponsor
Affiliated Hospital of Nantong University
1. Study Identification
Unique Protocol Identification Number
NCT05484687
Brief Title
Effect of Intravenous Infusion of Lidocaine on Patients Undergoing Radical Resection of Colorectal Tumors
Official Title
Effect of Intravenous Infusion of Lidocaine on Patients Undergoing Radical Resection of Colorectal Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
March 24, 2020 (Actual)
Primary Completion Date
December 30, 2021 (Actual)
Study Completion Date
January 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Affiliated Hospital of Nantong University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Colorectal cancer (CRC) is one of the most common malignant tumors in the world. Surgical resection is the main treatment option for colorectal cancer patients. Surgery may enhance or accelerate tumor recurrence and metastasis. Multiple factors in the tumor microenvironment play important roles in tumor recurrence and metastasis, and modulating the tumor microenvironment can inhibit disease progression. Lidocaine has been found to inhibit tumor growth in animal experiments.
Detailed Description
Lidocaine was applied in the operation of colorectal tumor patients, and the effect on the postoperative microenvironment and micrometastasis of the patients was observed by detecting the stress, immunity, vascular tumor regeneration, inflammation, etc. of the patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Tumors, Lidocaine
Keywords
Radical resection of colorectal tumor, lidocaine, stress, immunity, vascular tumor regeneration, inflammation, micrometastasis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lidocaine is used in radical resection of colorectal tumors.
Arm Type
Experimental
Arm Description
Administer 1.5 mg/kg intravenously to the patient before induction of anesthesia, and continue to infuse 1.5 mg/kg/h during the operation until the end of the operation
Intervention Type
Drug
Intervention Name(s)
Administer 1.5 mg/kg intravenously to the patient before induction of anesthesia, and continue to infuse 1.5 mg/kg/h during the operation until the end of the operation
Other Intervention Name(s)
same volume of saline
Intervention Description
Administer 1.5 mg/kg lidocaine
Primary Outcome Measure Information:
Title
the concentration of tumor micrometastasis markers were determined by ELISA
Description
the concentration of tumor micrometastasis markers such as CK20 was determined by ELISA
Time Frame
3 days after surgery
Secondary Outcome Measure Information:
Title
the concentration of stress hormones were determined by ELISA
Description
the concentration of EPI and NE were determined by ELISA
Time Frame
3 days after surgery
Title
the concentration of inflammatory factor were determined by ELISA
Description
the concentration of IL-6,IL-8,TNF-α were determined by ELISA
Time Frame
3 days after surgery
Title
the concentration of angiogenesis factors were determined by ELISA
Description
the concentration of VEGF was determined by ELISA
Time Frame
3 days after surgery
Title
the concentration of immune indexes were determined by ELISA
Description
the concentration of B lymphocytes, T lymphocytes, NK cells, macrophages were determined by ELISA
Time Frame
3 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
colorectal tumor patients
Exclusion Criteria:
Weight <45kg and >100kg
Sensitivity or hypersensitivity to lidocaine
Second or third degree heart block
Severe heart failure (ejection fraction < 20%)
History of active rhythm disorder
Acute severe liver and kidney injury
History of uncontrolled seizures
History of acute porphyria.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hongsheng chen
Organizational Affiliation
Chair
Official's Role
Principal Investigator
Facility Information:
Facility Name
Affiliated Hospital of Nantong University
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
226001
Country
China
12. IPD Sharing Statement
Learn more about this trial
Effect of Intravenous Infusion of Lidocaine on Patients Undergoing Radical Resection of Colorectal Tumors
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