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

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

NCT ID: NCT05560035

Condition: Cervical Cancer
Metastatic Cancer

Conditions: Official terms:
Uterine Cervical Neoplasms
Lidocaine

Conditions: Keywords:
Cervical cancer
Tumor progression
Lidocaine
Metalloproteinases
vascular endothelial growth factor
epidermal growth factor
thrombospondin2

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: Double (Participant, Care Provider)

Intervention:

Intervention type: Drug
Intervention name: Lidocaine
Description: Intravenous bolus of 1.5 mg/kg of lidocaine followed by a continuous infusion of 3.0 mg/kg for the frst hour, 1.5 mg/kg for the second hour, 0.7 mg/kg for the next 22h.
Arm group label: Lidocaine

Intervention type: Other
Intervention name: Normal saline (NS)
Description: Patients are received equal volumes of saline intravenously until the end of the surgery
Arm group label: Normal saline

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.

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.

Criteria for eligibility:
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

Gender: Female

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: No

Start date: December 1, 2022

Completion date: December 1, 2024

Lead sponsor:
Agency: General Hospital of Ningxia Medical University
Agency class: Other

Source: General Hospital of Ningxia Medical University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05560035