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NCT05560035 | Not yet recruiting | Cervical Cancer


The Effect of Intravenous Lidocaine on THBS2 and Angiogenic Factors Expression in Women Undergoing Cervical Cancer Surgery
Sponsor:

General Hospital of Ningxia Medical University

Brief Summary:

The purpose of this study is to investigate the efficacy of intravenous lidocaine on THBS2, MMPs and VEGF-C in serum in cervical cancer patients undergoing radical hysterectomy under general anesthesia.

Condition or disease

Cervical Cancer

Metastatic Cancer

Intervention/treatment

Lidocaine

Normal saline (NS)

Phase

Not Applicable

Detailed Description:

The surgical stress response to tumour removal causes bloodstream release of a variety of pro-inflammatory cytokines and other molecules which may affect perioperative immune response and other conditions conducive to residual tumour cell survival that could later emerge as clinical recurrences or metastasis. Lidocaine has analgesic and anti-inflammatory effects, and may also have specific anticancer properties. Blood serum expression of these molecules (metalloproteinases, vascular endothelial growth factor [VEGF], epidermal growth factor), play a important role in the metastatic process and tumor progression. lidocaine could affect the course and growth of metastatic tumors by changing the cancer cells, the tumor microenvironment, or both. We tested the hypothesis that women undergoing cervical cancer resection with these techniques (intravenous lidocaine) have reduced postoperative serum expression of metastasis biomarkers, and may change the outcomes of cancer patients.}}

Study Type : Interventional
Estimated Enrollment : 60 participants
Masking : Double
Primary Purpose : Prevention
Official Title : Effects of Intravenous Lidocaine on Serum THBS2, MMPS and VEGF-C in Patients Undergoing Radical Hyterectomy Surgery After General Anesthesia
Actual Study Start Date : December 1, 2022
Estimated Primary Completion Date : July 1, 2024
Estimated Study Completion Date : December 1, 2024
Arm Intervention/treatment

Experimental: Lidocaine

Intravenous bolus of 1.5 mg/kg of lidocaine followed by a continuous infusion of 3.0 mg/kg for the first hour, 1.5 mg/kg for the second hour, 0.7 mg/kg for the next 22h.

Drug: Lidocaine

Placebo Comparator: Normal saline

Normal saline administered as a bolus and an infusion with identical volume and rate changes as the treatment group.

Other: Normal saline (NS)

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Patients were scheduled by following cervical cancer surgery under general anesthesia
  • Aged 18-65 years
  • ASA physical status Ⅱ-Ⅲ
Exclusion Criteria
  • Severe heart, pulmonary, hepatic and renal insufficiency
  • History of neurological diseases
  • Autoimmune disorders
  • Antiarrhythmic drugs (amiodarone, verapamil, propafenone)
  • Patients' decision to withdraw anytime from the study, and refusal to participate before surgery and at postoperative follow-up
  • Allergy to one of the used medications
  • Psychiatric illness, psychological disorder, and drug or alcohol abuse
  • Unwillingness to comply with the protocol or procedures
  • Preoperative treatment of chemotherapy, radiation, NSAID and hormonal therapy
  • History of anesthesia and surgery in two weeks
  • Coexisting other cancers and intraoperative presence of liver metastasis
  • Perioperative treatment of blood transfusion

The Effect of Intravenous Lidocaine on THBS2 and Angiogenic Factors Expression in Women Undergoing Cervical Cancer Surgery

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The Effect of Intravenous Lidocaine on THBS2 and Angiogenic Factors Expression in Women Undergoing Cervical Cancer Surgery

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