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Completed

NCT Number: NCT04162834

Effect of Papaverine on Renal Artery Blood Flow Volume

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

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Key information

Conditions

Kidney Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Asan medical Center

Seoul, 05505, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Papaverine

Drug

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.

normal saline

Drug

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

Primary outcomes

  1. Renal artery blood flow

    Time frame: at 2 minutes after papaverine administration

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

Secondary outcomes

  1. estimated glomerular filtration rate

    Time frame: at postoperative day 0

    estimated glomerular filtration rate using KIDGO equation

  2. estimated glomerular filtration rate

    Time frame: at postoperative day 1

    estimated glomerular filtration rate using KIDGO equation

  3. estimated glomerular filtration rate

    Time frame: at postoperative day 4

    estimated glomerular filtration rate using KIDGO equation

  4. estimated glomerular filtration rate

    Time frame: at postoperative day 14

    estimated glomerular filtration rate using KIDGO equation

  5. estimated glomerular filtration rate

    Time frame: at postoperative month 3

    estimated glomerular filtration rate using KIDGO equation

  6. glomerular filtration rate using renal scan

    Time frame: at postoperative month 3

    glomerular filtration rate using renal scan

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 14, 2019
Registry last updated
Apr 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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