The Effect of Perioperative Lidocaine Infusion on Neutrophil Extracellular Trapping

NCT04840511 | Active Not Recruiting DMC

• 1 other identifier: NETosis-prostate Ca
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be done to investigate perioperative lidocaine infusion on neutrophil extracellular trapping in the patients undergoing the robot-assisted prostatectomy.

Conditions

Urologic Cancer

Outcome Measures

Primary Outcomes (1)

• Concentration of citrullinated histone3

  This will be obtained using ELISA.

  24 hours after surgery

Secondary Outcomes (2)

• Concentration of meyloperoxidase

  24 hours after surgery

• Concentration of neutrophil elastase

  24 hours after surgery

Other Outcomes (1)

• the severity of postoperative pain using NRS

  during postoperative 24 hours

Study Arms (2)

lidocaine group

EXPERIMENTAL

The study group receives perioperative lidocaine infusion with general anesthesia for robot-assisted prostatectomy

Drug: lidocaine group

control group

PLACEBO COMPARATOR

The control group receives normal saline infusion with with general anesthesia for robot-assisted prostatectomy

Drug: control group

Interventions

lidocaine group DRUG

lidocaine 1.5 mg/kg bolus (infused over 10 min) followed by 2.0 mg/kg/h during operation and 1.0 mg/kg/h during postoperative 24 hours (no more than 120 mg/h)

Also known as: lidocaine

lidocaine group

control group DRUG

normal saline 0.15 ml bolus followed by 0.2 ml/kg/hr during operation and 0.1 ml/kg/hr during postoperative 24 hours

Also known as: normal saline

control group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients scheduled robot-assisted prostatectomy

You may not qualify if:

• lidocaine allergy Hx
• hemodynamic unstable patients
• weight \< 40kg
• arrhythmia or bradycardia

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

Urologic Neoplasms

Interventions

Lidocaine; Control Groups; Saline Solution

Condition Hierarchy (Ancestors)

Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Young Eun Moon, MD, PhD

  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 7, 2021
• First Posted: April 12, 2021
• Study Start: September 27, 2021
• Primary Completion: April 30, 2022
• Study Completion (Estimated): April 30, 2027
• Last Updated: January 13, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)