The Effect of Perioperative Lidocaine Infusion on Neutrophil Extracellular Trapping

Not Applicable

Withdrawn

• Conditions: Gastric Cancer
• Interventions: Drug: normal saline; Drug: Lidocaine

• Registration Number: NCT04868747
• Lead Sponsor: The Catholic University of Korea

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2021-04-01
• Primary Completion: 2021-04-02
• Study Completion: 2021-04-02
• Study First Submitted: 2021-04-26
• Study First Submitted QC: 2021-04-29
• Study First Posted: 2021-05-03
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-10
• Last Update Posted: 2023-01-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	normal saline	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.
study group	Lidocaine	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).

Primary Outcome Measures

Name	Time	Method
serum concentration of NET(neutrophil extracellular trapping)-related biomarker	24 hours after surgery	NET-related biomarker (citrullinated histone3, neutrophil elastase, myeloperoxidase)

Secondary Outcome Measures

Name	Time	Method
survival of patients	5 years	The survival of patients is assessed using electronic medical record.
quality of recovery	24 hours after surgery	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.
postoperative pain	24 hours after surgery	The postoperative pain is assessed using numeric rating scale (NRS; 0=no pain, 10=the maximal pain)

Trial Locations

Locations (1)

Seoul St.Mary's Hospital; 🇰🇷 Seoul, Seocho-gu, Korea, Republic of