The Effect of Perioperative Lidocaine Infusion on Neutrophil Extracellular Trapping

NCT ID: NCT04840511

Last Updated: 2023-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-27

Study Completion Date

2027-04-30

Brief Summary

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

Detailed Description

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

Conditions

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Urologic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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lidocaine group

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

Group Type EXPERIMENTAL

lidocaine group

Intervention Type 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)

control group

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

Group Type PLACEBO_COMPARATOR

control group

Intervention Type 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

Interventions

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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)

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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lidocaine normal saline

Eligibility Criteria

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Inclusion Criteria

* patients scheduled robot-assisted prostatectomy

Exclusion Criteria

* lidocaine allergy Hx
* hemodynamic unstable patients
* weight \< 40kg
* arrhythmia or bradycardia
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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The Catholic University of Korea

OTHER

Sponsor Role lead

Responsible Party

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Young Eun Moon

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Young Eun Moon, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul St. Mary's Hospital

Locations

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Seoul St.Mary's Hospital

Seoul, Seocho-gu, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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NETosis-prostate Ca

Identifier Type: -

Identifier Source: org_study_id

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