The Effect of Perioperative Lidocaine Infusion on Neutrophil Extracellular Trapping

NCT04868747 | Withdrawn DMC

• 1 other identifier: NET-lidocaine-stomach cancer
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• serum concentration of NET(neutrophil extracellular trapping)-related biomarker

  NET-related biomarker (citrullinated histone3, neutrophil elastase, myeloperoxidase)

  24 hours after surgery

Secondary Outcomes (3)

• quality of recovery

  24 hours after surgery

• postoperative pain

  24 hours after surgery

• survival of patients

  5 years

Study Arms (2)

study group

EXPERIMENTAL

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

control group

PLACEBO COMPARATOR

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

Interventions

Lidocaine DRUG

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

study group

normal saline DRUG

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

control group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of stomach cancer
• ASA class I-III
• no metastatic disease

You may not qualify if:

• 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

Sponsors & Collaborators

• The Catholic University of Korea: lead

Study Sites (1)

Seoul St.Mary's Hospital

Seoul, Seocho-gu, 07651, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Lidocaine; Saline Solution

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Young Eun Moon, MD

  Seoul St. Mary's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: May 3, 2021
• Study Start: April 1, 2021
• Primary Completion: April 2, 2021
• Study Completion: April 2, 2021
• Last Updated: January 12, 2023

Record last verified: 2023-01

Locations

KR (1)