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Effect of Papaverine on Renal Artery Blood Flow Volume

Primary Purpose

Kidney Cancer

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Papaverine
Normal saline
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Kidney Cancer

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Asan medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Papaverine group

Normal saline group

Arm Description

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.

Immediately after the renal artery declamping, normal saline 6 ml is sprinkled around the renal artery.

Outcomes

Primary Outcome Measures

Renal artery blood flow
Renal artery blood flow 2 minutes after papaverine administration by doppler sonography

Secondary Outcome Measures

estimated glomerular filtration rate
estimated glomerular filtration rate using KIDGO equation
estimated glomerular filtration rate
estimated glomerular filtration rate using KIDGO equation
estimated glomerular filtration rate
estimated glomerular filtration rate using KIDGO equation
estimated glomerular filtration rate
estimated glomerular filtration rate using KIDGO equation
estimated glomerular filtration rate
estimated glomerular filtration rate using KIDGO equation
glomerular filtration rate using renal scan
glomerular filtration rate using renal scan

Full Information

First Posted
November 10, 2019
Last Updated
April 15, 2021
Sponsor
Asan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04162834
Brief Title
Effect of Papaverine on Renal Artery Blood Flow Volume
Official Title
Effect of Papaverine on Intraoperative Renal Artery Blood Flow Volume in Patients Undergoing Robot-assisted Partial Nephrectomy : a Randomized, Placebo-controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
November 21, 2019 (Actual)
Primary Completion Date
April 15, 2021 (Actual)
Study Completion Date
April 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center

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

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Papaverine group
Arm Type
Experimental
Arm Description
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.
Arm Title
Normal saline group
Arm Type
Active Comparator
Arm Description
Immediately after the renal artery declamping, normal saline 6 ml is sprinkled around the renal artery.
Intervention Type
Drug
Intervention Name(s)
Papaverine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
Immediately after the renal artery declamping, normal saline 6 ml is sprinkled around the renal artery.
Primary Outcome Measure Information:
Title
Renal artery blood flow
Description
Renal artery blood flow 2 minutes after papaverine administration by doppler sonography
Time Frame
at 2 minutes after papaverine administration
Secondary Outcome Measure Information:
Title
estimated glomerular filtration rate
Description
estimated glomerular filtration rate using KIDGO equation
Time Frame
at postoperative day 0
Title
estimated glomerular filtration rate
Description
estimated glomerular filtration rate using KIDGO equation
Time Frame
at postoperative day 1
Title
estimated glomerular filtration rate
Description
estimated glomerular filtration rate using KIDGO equation
Time Frame
at postoperative day 4
Title
estimated glomerular filtration rate
Description
estimated glomerular filtration rate using KIDGO equation
Time Frame
at postoperative day 14
Title
estimated glomerular filtration rate
Description
estimated glomerular filtration rate using KIDGO equation
Time Frame
at postoperative month 3
Title
glomerular filtration rate using renal scan
Description
glomerular filtration rate using renal scan
Time Frame
at postoperative month 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young-Kug Kim, MD,PhD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Papaverine on Renal Artery Blood Flow Volume

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