Effect of Papaverine on Renal Artery Blood Flow Volume

April 15, 2021 updated by: Young-Kug Kim, MD, Asan Medical Center

Effect of Papaverine on Intraoperative Renal Artery Blood Flow Volume in Patients Undergoing Robot-assisted Partial Nephrectomy : a Randomized, Placebo-controlled Study

The purpose of this study is to evaluate the effect of papaverine on renal artery blood flow after declamping of renal artery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to evaluate the effect of papaverine on renal artery blood flow after declamping of renal artery in patients undergoing robot assisted partial nephrectomy.

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 79 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients diagnosed with kidney cancer.
  • Patients undergoing robot assisted partial nephrectomy under general anesthesia
  • 20 years old ≤ age <80 years old
  • Patients who voluntarily agreed to this clinical study
  • eGFR ≥ 60 ml / min / 1.73 m2 (Chronic Kidney Disease Epidemiology Patients with Collaboration)

Exclusion Criteria:

  • The tumor ≥ 7 cm in size
  • Multiple renal mass
  • If the surgery plan is changed due to open
  • When surgery is performed together with other surgery
  • Multiple renal artery
  • Patients with hypersensitivity to papaverine
  • Patients with atrioventricular block
  • Pregnant and lactating women
  • Patients using levodopa
  • Refusal of patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Papaverine group
Immediately after the renal artery declamping, papaverine 30 mg (1 ample, 1 ml) is mixed with 5 ml of normal saline (total 6 ml) and sprinkled around the renal artery.
Drug: Papaverine
Immediately after the renal artery declamping, papaverine 30 mg (1 ample, 1 ml) is mixed with 5 ml of normal saline (total 6 ml) and sprinkled around the renal artery.
ACTIVE_COMPARATOR: Normal saline group
Immediately after the renal artery declamping, normal saline 6 ml is sprinkled around the renal artery.
Drug: Normal saline
Immediately after the renal artery declamping, normal saline 6 ml is sprinkled around the renal artery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Renal artery blood flow
Time Frame: at 2 minutes after papaverine administration
Renal artery blood flow 2 minutes after papaverine administration by doppler sonography
at 2 minutes after papaverine administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
estimated glomerular filtration rate
Time Frame: at postoperative day 0
estimated glomerular filtration rate using KIDGO equation
at postoperative day 0
estimated glomerular filtration rate
Time Frame: at postoperative day 1
estimated glomerular filtration rate using KIDGO equation
at postoperative day 1
estimated glomerular filtration rate
Time Frame: at postoperative day 4
estimated glomerular filtration rate using KIDGO equation
at postoperative day 4
estimated glomerular filtration rate
Time Frame: at postoperative day 14
estimated glomerular filtration rate using KIDGO equation
at postoperative day 14
estimated glomerular filtration rate
Time Frame: at postoperative month 3
estimated glomerular filtration rate using KIDGO equation
at postoperative month 3
glomerular filtration rate using renal scan
Time Frame: at postoperative month 3
glomerular filtration rate using renal scan
at postoperative month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 21, 2019

Primary Completion (ACTUAL)

April 15, 2021

Study Completion (ACTUAL)

April 15, 2021

Study Registration Dates

First Submitted

November 10, 2019

First Submitted That Met QC Criteria

November 12, 2019

First Posted (ACTUAL)

November 14, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 19, 2021

Last Update Submitted That Met QC Criteria

April 15, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20191111

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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