The Effect of Perioperative Lidocaine Infusion on Neutrophil Extracellular Trapping

Sponsor

The Catholic University of Korea (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04868747

Collaborator

(none)

Enrollment

Location

Arms

78.9

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer	Drug: Lidocaine Drug: normal saline	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

May 5, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2027

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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)
survival of patients [5 years]
The survival of patients is assessed using electronic medical record.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul St.Mary's Hospital	Seoul	Seocho-gu	Korea, Republic of	07651

Sponsors and Collaborators

The Catholic University of Korea

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Young Eun Moon, Associate professor, The Catholic University of Korea

ClinicalTrials.gov Identifier:

NCT04868747

Other Study ID Numbers:

NET-lidocaine-stomach cancer

First Posted:

May 3, 2021

Last Update Posted:

May 3, 2021

Last Verified:

Apr 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Stomach Neoplasms

Lidocaine

Study Results

No Results Posted as of May 3, 2021