The Effect of Perioperative Lidocaine Infusion on Neutrophil Extracellular Trapping

January 10, 2023 updated by: Young Eun Moon, The Catholic University of Korea

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Seocho-gu
      • Seoul, Seocho-gu, Korea, Republic of, 07651
        • Seoul St.Mary's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: study group
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
The participants receive perioperative lidocaine infusion with general anesthesia for gastrectomy.
Placebo Comparator: control group
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
The participants receive perioperative normal slaine infusion with general anesthesia for gastrectomy.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Catholic University of Korea

Investigators

  • Principal Investigator: Young Eun Moon, MD, Seoul St. Mary's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Actual)

April 2, 2021

Study Completion (Actual)

April 2, 2021

Study Registration Dates

First Submitted

April 26, 2021

First Submitted That Met QC Criteria

April 29, 2021

First Posted (Actual)

May 3, 2021

Study Record Updates

Last Update Posted (Actual)

January 12, 2023

Last Update Submitted That Met QC Criteria

January 10, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NET-lidocaine-stomach cancer

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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