Effect of Papaverine on Renal Artery Blood Flow Volume

Phase 4

Completed

• Conditions: Kidney Cancer
• Interventions: Drug: Normal saline; Drug: Papaverine

• Registration Number: NCT04162834
• Lead Sponsor: Asan Medical Center

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.

Study Timeline

• Study First Submitted: 2019-11-10
• Study First Submitted QC: 2019-11-12
• Study First Posted: 2019-11-14
• Study Start: 2019-11-21
• Status Verified: 2021-04
• Primary Completion: 2021-04-15
• Study Completion: 2021-04-15
• Last Update Submitted: 2021-04-15
• Last Update Posted: 2021-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal saline group	Normal saline	Immediately after the renal artery declamping, normal saline 6 ml is sprinkled around the renal artery.
Papaverine group	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.

Primary Outcome Measures

Name	Time	Method
Renal artery blood flow	at 2 minutes after papaverine administration	Renal artery blood flow 2 minutes after papaverine administration by doppler sonography

Secondary Outcome Measures

Name	Time	Method
glomerular filtration rate using renal scan	at postoperative month 3	glomerular filtration rate using renal scan
estimated glomerular filtration rate	at postoperative month 3	estimated glomerular filtration rate using KIDGO equation

Trial Locations

Locations (1)

Asan medical Center; 🇰🇷 Seoul, Korea, Republic of