The Effect of Perioperative Lidocaine Infusion on Neutrophil Extracellular Trapping

Study Overview
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Brief Summary
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To investigate the effect of perioperative lidocaine infusion on the neutrophil extracellular trapping after minimally invasive surgery for stomach cancer

Detailed Description
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To investigate the effect of perioperative lidocaine infusion on the neutrophil extracellular trapping, especially citrullinated histone3, neutrophil elastase, myeloperoxidase

Official Title
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The Effect of Perioperative Lidocaine Intravenous Infusion on Neutrophil Extracellular Trapping After Surgery for Stomach Cancer

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: Lidocaine
* Drug: normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of stomach cancer ASA class I-III no metastatic disease Exclusion Criteria: hepatic, renal disease chronic inflammatory disease, eg. rheumatoid arthritis steroid or anti-inflammatory drug medication allergies to study drugs neuropsychiatric disease refusal of participation breast feeding or pregnancy weight < 40 kg

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study group<br>The study group receives the intravenous 1% lidocaine 1.5 mg/kg bolus followed by 1.5 mg/kg/h during surgery and 1.0 mg/kg/h until 24 hours after surgery (Max.<120 mg/h). | Drug: Lidocaine<br>* The participants receive perioperative lidocaine infusion with general anesthesia for gastrectomy.<br>|
| Placebo Comparator: control group<br>The control group receives intravenous normal saline 0.15 ml/kg bolus followed by 0.15 ml/kg/h during surgery and 0.1 mg/kg/h until 24 hours after surgery. | Drug: normal saline<br>* The participants receive perioperative normal slaine infusion with general anesthesia for gastrectomy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum concentration of NET(neutrophil extracellular trapping)-related biomarker | NET-related biomarker (citrullinated histone3, neutrophil elastase, myeloperoxidase) | 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of recovery | The quality of recovery is assessed using questionnaire. This questionnaire includes 15 items. The score range is from 0 to 150. The higher score means the better quality of recovery after surgery. | 24 hours after surgery | 
| postoperative pain | The postoperative pain is assessed using numeric rating scale (NRS; 0=no pain, 10=the maximal pain) | 24 hours after surgery | 
| survival of patients | The survival of patients is assessed using electronic medical record. | 5 years |