Effect of Intravenous Infusion of Lidocaine on Patients Undergoing Radical Resection of Colorectal Tumors

Lidocaine Clinical Trial

Official title:

Effect of Intravenous Infusion of Lidocaine on Patients Undergoing Radical Resection of Colorectal Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05484687
• Other study ID #: MA2021008
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Colorectal Tumors
• Lidocaine

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