Effect of Papaverine on Renal Artery Blood Flow Volume

Kidney Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04162834
• Other study ID #: 20191111
• Status: Completed
• Phase: Phase 4
• Start date: November 21, 2019
• Est. completion date: April 15, 2021

Study information

• Verified date: April 2021
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: April 15, 2021
• Est. primary completion date: April 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Kidney Cancer
• Kidney Neoplasms

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Asan medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal artery blood flow	Renal artery blood flow 2 minutes after papaverine administration by doppler sonography	at 2 minutes after papaverine administration
Secondary	estimated glomerular filtration rate	estimated glomerular filtration rate using KIDGO equation	at postoperative day 0
Secondary	estimated glomerular filtration rate	estimated glomerular filtration rate using KIDGO equation	at postoperative day 1
Secondary	estimated glomerular filtration rate	estimated glomerular filtration rate using KIDGO equation	at postoperative day 4
Secondary	estimated glomerular filtration rate	estimated glomerular filtration rate using KIDGO equation	at postoperative day 14
Secondary	estimated glomerular filtration rate	estimated glomerular filtration rate using KIDGO equation	at postoperative month 3
Secondary	glomerular filtration rate using renal scan	glomerular filtration rate using renal scan	at postoperative month 3