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

Not Applicable

Completed

• Conditions: Lidocaine; Colorectal Tumors
• Interventions: 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

• Registration Number: NCT05484687
• Lead Sponsor: Affiliated Hospital of Nantong University

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.

Study Timeline

• Study Start: 2020-03-24
• Primary Completion: 2021-12-30
• Status Verified: 2022-01
• Study First Submitted: 2022-07-27
• Study First Submitted QC: 2022-07-31
• Study First Posted: 2022-08-02
• Study Completion: 2023-01-30
• Last Update Submitted: 2023-07-31
• Last Update Posted: 2023-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
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	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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 stress hormones were determined by ELISA	3 days after surgery	the concentration of EPI and NE 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

Trial Locations

Locations (1)

Affiliated Hospital of Nantong University; 🇨🇳 Nantong, Jiangsu, China