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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04868747
Other study ID # NET-lidocaine-stomach cancer
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date April 1, 2021
Est. completion date April 2, 2021

Study information

Verified date January 2023
Source The Catholic University of Korea
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date April 2, 2021
Est. primary completion date April 2, 2021
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Lidocaine
The participants receive perioperative lidocaine infusion with general anesthesia for gastrectomy.
normal saline
The participants receive perioperative normal slaine infusion with general anesthesia for gastrectomy.

Locations

Country Name City State
Korea, Republic of Seoul St.Mary's Hospital Seoul Seocho-gu

Sponsors (1)

Lead Sponsor Collaborator
The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary serum concentration of NET(neutrophil extracellular trapping)-related biomarker NET-related biomarker (citrullinated histone3, neutrophil elastase, myeloperoxidase) 24 hours after surgery
Secondary 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. 24 hours after surgery
Secondary postoperative pain The postoperative pain is assessed using numeric rating scale (NRS; 0=no pain, 10=the maximal pain) 24 hours after surgery
Secondary survival of patients The survival of patients is assessed using electronic medical record. 5 years
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