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Completed

NCT Number: NCT05484687

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

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.

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Key information

Conditions

Colorectal Tumors Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Inflammation Intestinal Diseases Intestinal Neoplasms Lidocaine Neoplasm Metastasis Neoplasm Micrometastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases

Age range

30 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226001, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: same volume of saline

Primary outcomes

  1. the concentration of tumor micrometastasis markers were determined by ELISA

    Time frame: 3 days after surgery

    the concentration of tumor micrometastasis markers such as CK20 was determined by ELISA

Secondary outcomes

  1. the concentration of stress hormones were determined by ELISA

    Time frame: 3 days after surgery

    the concentration of EPI and NE were determined by ELISA

  2. the concentration of inflammatory factor were determined by ELISA

    Time frame: 3 days after surgery

    the concentration of IL-6,IL-8,TNF-α were determined by ELISA

  3. the concentration of angiogenesis factors were determined by ELISA

    Time frame: 3 days after surgery

    the concentration of VEGF was determined by ELISA

  4. the concentration of immune indexes were determined by ELISA

    Time frame: 3 days after surgery

    the concentration of B lymphocytes, T lymphocytes, NK cells, macrophages were determined by ELISA

Sponsors and collaborators

Lead sponsor

Affiliated Hospital of Nantong University

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2023
First posted
Aug 2, 2022
Registry last updated
Aug 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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