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Effect of Papaverine on Renal Artery Blood Flow Volume

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04162834
Enrollment
96
Registered
2019-11-14
Start date
2019-11-21
Completion date
2021-04-15
Last updated
2021-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Cancer

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.

Interventions

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.

DRUGNormal saline

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

Sponsors

Asan Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Renal artery blood flowat 2 minutes after papaverine administrationRenal artery blood flow 2 minutes after papaverine administration by doppler sonography

Secondary

MeasureTime frameDescription
estimated glomerular filtration rateat postoperative day 0estimated glomerular filtration rate using KIDGO equation
glomerular filtration rate using renal scanat postoperative month 3glomerular filtration rate using renal scan

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026