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

Sponsor

Affiliated Hospital of Nantong University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05484687

Collaborator

(none)

100

Enrollment

Location

Arm

45.2

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Tumors Lidocaine	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	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Mar 24, 2020

Anticipated Primary Completion Date :

Dec 30, 2022

Anticipated Study Completion Date :

Dec 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lidocaine is used in radical resection of colorectal tumors. 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	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 Other Names: same volume of saline

Arm

Intervention/Treatment

Experimental: Lidocaine is used in radical resection of colorectal tumors.

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

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

Other Names:

same volume of saline

Outcome Measures

Primary Outcome Measures

the concentration of tumor micrometastasis markers were determined by ELISA [3 days after surgery]
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 [3 days after surgery]
the concentration of EPI and NE were determined by ELISA
the concentration of inflammatory factor were determined by ELISA [3 days after surgery]
the concentration of IL-6,IL-8,TNF-α were determined by ELISA
the concentration of angiogenesis factors were determined by ELISA [3 days after surgery]
the concentration of VEGF was determined by ELISA
the concentration of immune indexes were determined by ELISA [3 days after surgery]
the concentration of B lymphocytes, T lymphocytes, NK cells, macrophages were determined by ELISA