Effect of Papaverine on Renal Artery Blood Flow Volume

• Sponsor: Asan Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT04162834
• Collaborator: (none)
• Enrollment: 96
• Location: 1
• Arms: 2
• Actual Duration (Months): 16.8
• Patients Per Site Per Month: 5.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Cancer	Drug: Papaverine; Drug: Normal saline	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 96 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Effect of Papaverine on Intraoperative Renal Artery Blood Flow Volume in Patients Undergoing Robot-assisted Partial Nephrectomy : a Randomized, Placebo-controlled Study
• Actual Study Start Date: Nov 21, 2019
• Actual Primary Completion Date: Apr 15, 2021
• Actual Study Completion Date: Apr 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Papaverine group 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.	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.
Active Comparator: Normal saline group Immediately after the renal artery declamping, normal saline 6 ml is sprinkled around the renal artery.	Drug: Normal saline; Immediately after the renal artery declamping, normal saline 6 ml is sprinkled around the renal artery.

Outcome Measures

Primary Outcome Measures

1. 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

1. estimated glomerular filtration rate [at postoperative day 0]

   estimated glomerular filtration rate using KIDGO equation

2. estimated glomerular filtration rate [at postoperative day 1]

   estimated glomerular filtration rate using KIDGO equation

3. estimated glomerular filtration rate [at postoperative day 4]

   estimated glomerular filtration rate using KIDGO equation

4. estimated glomerular filtration rate [at postoperative day 14]

   estimated glomerular filtration rate using KIDGO equation

5. estimated glomerular filtration rate [at postoperative month 3]

   estimated glomerular filtration rate using KIDGO equation

6. glomerular filtration rate using renal scan [at postoperative month 3]

   glomerular filtration rate using renal scan

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 79 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asan medical Center	Seoul		Korea, Republic of	05505

Sponsors and Collaborators

• Asan Medical Center

Investigators

• Principal Investigator: Young-Kug Kim, MD,PhD, Asan Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Young-Kug Kim, MD, Principal Investigator, Asan Medical Center
• ClinicalTrials.gov Identifier: NCT04162834
• Other Study ID Numbers: 20191111
• First Posted: Nov 14, 2019
• Last Update Posted: Apr 19, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Kidney Neoplasms; Papaverine

Study Results

No Results Posted as of Apr 19, 2021