search
Back to results

The Effect of Perioperative Lidocaine Infusion on Neutrophil Extracellular Trapping

Primary Purpose

Urologic Cancer

Status
Active
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
lidocaine group
control group
Sponsored by
The Catholic University of Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Urologic Cancer

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • patients scheduled robot-assisted prostatectomy

Exclusion Criteria:

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

Sites / Locations

  • Seoul St.Mary's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

lidocaine group

control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Concentration of citrullinated histone3
This will be obtained using ELISA.

Secondary Outcome Measures

Concentration of meyloperoxidase
This will be obtained using ELISA.
Concentration of neutrophil elastase
This will be obtained using ELISA.

Full Information

First Posted
April 7, 2021
Last Updated
January 11, 2023
Sponsor
The Catholic University of Korea
search

1. Study Identification

Unique Protocol Identification Number
NCT04840511
Brief Title
The Effect of Perioperative Lidocaine Infusion on Neutrophil Extracellular Trapping
Official Title
The Effect of Perioperative Lidocaine Infusion on Neutrophil Extracellular Trapping in the Patients Undergoing the Robot-assisted Prostatectomy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 27, 2021 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
April 30, 2027 (Anticipated)

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
This study will be done to investigate perioperative lidocaine infusion on neutrophil extracellular trapping in the patients undergoing the robot-assisted prostatectomy.
Detailed Description
Neutrophil extracellular trapping by analyzing the meyloperoxidase, neutrophil elastase, citrullinated histone3

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urologic Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
lidocaine group
Arm Type
Experimental
Arm Description
The study group receives perioperative lidocaine infusion with general anesthesia for robot-assisted prostatectomy
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
The control group receives normal saline infusion with with general anesthesia for robot-assisted prostatectomy
Intervention Type
Drug
Intervention Name(s)
lidocaine group
Other Intervention Name(s)
lidocaine
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
control group
Other Intervention Name(s)
normal saline
Intervention Description
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
Primary Outcome Measure Information:
Title
Concentration of citrullinated histone3
Description
This will be obtained using ELISA.
Time Frame
24 hours after surgery
Secondary Outcome Measure Information:
Title
Concentration of meyloperoxidase
Description
This will be obtained using ELISA.
Time Frame
24 hours after surgery
Title
Concentration of neutrophil elastase
Description
This will be obtained using ELISA.
Time Frame
24 hours after surgery
Other Pre-specified Outcome Measures:
Title
the severity of postoperative pain using NRS
Description
This will be measured using NRS (numeric rating scale; 0=no pain, 10=the worst pain)
Time Frame
during postoperative 24 hours

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients scheduled robot-assisted prostatectomy Exclusion Criteria: lidocaine allergy Hx hemodynamic unstable patients weight < 40kg arrhythmia or bradycardia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young Eun Moon, MD, PhD
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

Plan to Share IPD
No

Learn more about this trial

The Effect of Perioperative Lidocaine Infusion on Neutrophil Extracellular Trapping

We'll reach out to this number within 24 hrs