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

NCT05484687 | Completed

• 1 other identifier: MA2021008
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Tumors; Lidocaine

Keywords

Radical resection of colorectal tumor; lidocaine; stress; immunity; vascular tumor regeneration; inflammation; micrometastasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• the concentration of stress hormones were determined by ELISA

  3 days after surgery

• the concentration of inflammatory factor were determined by ELISA

  3 days after surgery

• the concentration of angiogenesis factors were determined by ELISA

  3 days after surgery

• the concentration of immune indexes were determined by ELISA

  3 days after surgery

Study Arms (1)

Lidocaine is used in radical resection of colorectal tumors.

EXPERIMENTAL

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

Interventions

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 lidocaine

Also known as: same volume of saline

Lidocaine is used in radical resection of colorectal tumors.

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• colorectal tumor patients

You may not qualify if:

• 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.

Sponsors & Collaborators

• Affiliated Hospital of Nantong University: lead

Study Sites (1)

Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226001, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Inflammation; Neoplasm Micrometastasis

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasm Metastasis; Neoplastic Processes

Study Officials

• hongsheng chen

  Chair

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2022
• First Posted: August 2, 2022
• Study Start: March 24, 2020
• Primary Completion: December 30, 2021
• Study Completion: January 30, 2023
• Last Updated: August 2, 2023

Record last verified: 2022-01

Locations

CN (1)