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The Effect of Perioperative Lidocaine Infusion on Neutrophil Extracellular Trapping

Sponsor
The Catholic University of Korea (Other)
Overall Status
Recruiting
CT.gov ID
NCT04840511
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
12
Anticipated Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: lidocaine group
  • Drug: control group
 N/A

Detailed Description

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

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 Infusion on Neutrophil Extracellular Trapping in the Patients Undergoing the Robot-assisted Prostatectomy
Actual Study Start Date :
Sep 27, 2021
Anticipated Primary Completion Date :
Sep 27, 2022
Anticipated Study Completion Date :
Sep 27, 2022

Arms and Interventions

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 0.15 ml/kg/hr during operation and 0.2 ml/kg/hr during postoperative 24 hours
    Other Names:
  • normal saline

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Concentration of citrullinated histone3 [24 hours after surgery]

      This will be obtained using ELISA.

    Secondary Outcome Measures

    1. Concentration of meyloperoxidase [24 hours after surgery]

      This will be obtained using ELISA.

    2. Concentration of neutrophil elastase [24 hours after surgery]

      This will be obtained using ELISA.

    Other Outcome Measures

    1. the severity of postoperative pain using NRS [during postoperative 24 hours]

      This will be measured using NRS (numeric rating scale; 0=no pain, 10=the worst pain)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 75 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • patients scheduled robot-assisted prostatectomy
    Exclusion Criteria:

    • lidocaine allergy Hx

    • hemodynamic unstable patients

    • weight < 40kg

    • arrhythmia or bradycardia

    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, PhD, 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:
    NCT04840511
    Other Study ID Numbers:
    • NETosis-prostate Ca
    First Posted:
    Apr 12, 2021
    Last Update Posted:
    Oct 1, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Urologic Neoplasms
    Lidocaine

    Study Results

    No Results Posted as of Oct 1, 2021