Back to resultsThe Effect of Perioperative Lidocaine Infusion on Neutrophil Extracellular Trapping
Primary Purpose
Gastric Cancer
Status
Withdrawn
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Lidocaine
normal saline
Sponsored by
About this trial
This is an interventional supportive care trial for Gastric Cancer
Eligibility Criteria
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
Sites / Locations
- Seoul St.Mary's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
study group
control group
Arm Description
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).
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.
Outcomes
Primary Outcome Measures
serum concentration of NET(neutrophil extracellular trapping)-related biomarker
NET-related biomarker (citrullinated histone3, neutrophil elastase, myeloperoxidase)
Secondary Outcome Measures
quality of recovery
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
The postoperative pain is assessed using numeric rating scale (NRS; 0=no pain, 10=the maximal pain)
survival of patients
The survival of patients is assessed using electronic medical record.
Full Information
NCT ID
NCT04868747
First Posted
April 26, 2021
Last Updated
January 10, 2023
Sponsor
The Catholic University of Korea
1. Study Identification
Unique Protocol Identification Number
NCT04868747
Brief Title
The Effect of Perioperative Lidocaine Infusion on Neutrophil Extracellular Trapping
Official Title
The Effect of Perioperative Lidocaine Intravenous Infusion on Neutrophil Extracellular Trapping After Surgery for Stomach Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Withdrawn
Why Stopped
due to financial problem
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
April 2, 2021 (Actual)
Study Completion Date
April 2, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Catholic University of Korea
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
study group
Arm Type
Experimental
Arm Description
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).
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
The participants receive perioperative lidocaine infusion with general anesthesia for gastrectomy.
Intervention Type
Drug
Intervention Name(s)
normal saline
Intervention Description
The participants receive perioperative normal slaine infusion with general anesthesia for gastrectomy.
Primary Outcome Measure Information:
Title
serum concentration of NET(neutrophil extracellular trapping)-related biomarker
Description
NET-related biomarker (citrullinated histone3, neutrophil elastase, myeloperoxidase)
Time Frame
24 hours after surgery
Secondary Outcome Measure Information:
Title
quality of recovery
Description
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.
Time Frame
24 hours after surgery
Title
postoperative pain
Description
The postoperative pain is assessed using numeric rating scale (NRS; 0=no pain, 10=the maximal pain)
Time Frame
24 hours after surgery
Title
survival of patients
Description
The survival of patients is assessed using electronic medical record.
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young Eun Moon, MD
Organizational Affiliation
Seoul St. Mary's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul St.Mary's Hospital
City
Seoul
State/Province
Seocho-gu
ZIP/Postal Code
07651
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
The Effect of Perioperative Lidocaine Infusion on Neutrophil Extracellular Trapping
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