The Effect of Perioperative Lidocaine Infusion on Neutrophil Extracellular Trapping

The Effect of Perioperative Lidocaine Infusion on Neutrophil Extracellular Trapping in the Patients Undergoing the Robot-assisted Prostatectomy

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

Study Overview

• Status: Active, not recruiting
• Conditions: Urologic Cancer
• Intervention / Treatment: Drug: lidocaine group; Drug: control group

Detailed Description

Neutrophil extracellular trapping by analyzing the meyloperoxidase, neutrophil elastase, citrullinated histone3

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seocho-gu
    • Seoul, Seocho-gu, Korea, Republic of, 07651
      • Seoul St.Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• patients scheduled robot-assisted prostatectomy

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: lidocaine group; The study group receives perioperative lidocaine infusion with general anesthesia for robot-assisted prostatectomy	Drug: lidocaine group; 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); Other Names: lidocaine
Placebo Comparator: control group; The control group receives normal saline infusion with with general anesthesia for robot-assisted prostatectomy	Drug: control group; 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; Other Names: normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of citrullinated histone3	This will be obtained using ELISA.	24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of meyloperoxidase	This will be obtained using ELISA.	24 hours after surgery
Concentration of neutrophil elastase	This will be obtained using ELISA.	24 hours after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
the severity of postoperative pain using NRS	This will be measured using NRS (numeric rating scale; 0=no pain, 10=the worst pain)	during postoperative 24 hours

Collaborators and Investigators

• Sponsor: The Catholic University of Korea
• Investigators: Principal Investigator: Young Eun Moon, MD, PhD, Seoul ST. Mary's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2021
• Primary Completion (Actual): April 30, 2022
• Study Completion (Anticipated): April 30, 2027

Study Registration Dates

• First Submitted: April 7, 2021
• First Submitted That Met QC Criteria: April 7, 2021
• First Posted (Actual): April 12, 2021

Study Record Updates

• Last Update Posted (Actual): January 13, 2023
• Last Update Submitted That Met QC Criteria: January 11, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: NETosis-prostate Ca

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No