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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05484687
Other study ID # MA2021008
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 24, 2020
Est. completion date January 30, 2023

Study information

Verified date January 2022
Source Affiliated Hospital of Nantong University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date January 30, 2023
Est. primary completion date December 30, 2021
Accepts healthy volunteers No
Gender All
Age group 30 Years to 85 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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
Administer 1.5 mg/kg lidocaine

Locations

Country Name City State
China Affiliated Hospital of Nantong University Nantong Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
Affiliated Hospital of Nantong University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary the concentration of tumor micrometastasis markers were determined by ELISA the concentration of tumor micrometastasis markers such as CK20 was determined by ELISA 3 days after surgery
Secondary the concentration of stress hormones were determined by ELISA the concentration of EPI and NE were determined by ELISA 3 days after surgery
Secondary the concentration of inflammatory factor were determined by ELISA the concentration of IL-6,IL-8,TNF-a were determined by ELISA 3 days after surgery
Secondary the concentration of angiogenesis factors were determined by ELISA the concentration of VEGF was determined by ELISA 3 days after surgery
Secondary the concentration of immune indexes were determined by ELISA the concentration of B lymphocytes, T lymphocytes, NK cells, macrophages were determined by ELISA 3 days after surgery
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