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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04840511
Other study ID # NETosis-prostate Ca
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 27, 2021
Est. completion date April 30, 2027

Study information

Verified date January 2023
Source The Catholic University of Korea
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 60
Est. completion date April 30, 2027
Est. primary completion date April 30, 2022
Accepts healthy volunteers No
Gender Male
Age group 20 Years to 75 Years
Eligibility Inclusion Criteria: - patients scheduled robot-assisted prostatectomy Exclusion Criteria: - lidocaine allergy Hx - hemodynamic unstable patients - weight < 40kg - arrhythmia or bradycardia

Study Design


Related Conditions & MeSH terms


Intervention

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)
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

Locations

Country Name City State
Korea, Republic of Seoul St.Mary's Hospital Seoul Seocho-gu

Sponsors (1)

Lead Sponsor Collaborator
The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Other 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
Primary Concentration of citrullinated histone3 This will be obtained using ELISA. 24 hours after surgery
Secondary Concentration of meyloperoxidase This will be obtained using ELISA. 24 hours after surgery
Secondary Concentration of neutrophil elastase This will be obtained using ELISA. 24 hours after surgery
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