The Effect of Perioperative Lidocaine Infusion on Neutrophil Extracellular Trapping

NCT ID: NCT04868747

Last Updated: 2023-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2021-04-02

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

Conditions

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Gastric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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).

Group Type EXPERIMENTAL

Lidocaine

Intervention Type DRUG

The participants receive perioperative lidocaine infusion with general anesthesia for gastrectomy.

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.

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type DRUG

The participants receive perioperative normal slaine infusion with general anesthesia for gastrectomy.

Interventions

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Lidocaine

The participants receive perioperative lidocaine infusion with general anesthesia for gastrectomy.

Intervention Type DRUG

normal saline

The participants receive perioperative normal slaine infusion with general anesthesia for gastrectomy.

Intervention Type DRUG

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Catholic University of Korea

OTHER

Sponsor Role lead

Responsible Party

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Young Eun Moon

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Young Eun Moon, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul St. Mary's Hospital

Locations

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Seoul St.Mary's Hospital

Seoul, Seocho-gu, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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NET-lidocaine-stomach cancer

Identifier Type: -

Identifier Source: org_study_id

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