Effect of Papaverine on Renal Artery Blood Flow Volume

NCT04162834 | Completed Phase 4 DMC

• 1 other identifier: 20191111
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Kidney Cancer

Outcome Measures

Primary Outcomes (1)

• Renal artery blood flow

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

  at 2 minutes after papaverine administration

Secondary Outcomes (6)

• estimated glomerular filtration rate

  at postoperative day 0

• estimated glomerular filtration rate

  at postoperative day 1

• estimated glomerular filtration rate

  at postoperative day 4

• estimated glomerular filtration rate

  at postoperative day 14

• estimated glomerular filtration rate

  at postoperative month 3

Study Arms (2)

Papaverine group

EXPERIMENTAL

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

Normal saline group

ACTIVE COMPARATOR

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

Drug: Normal saline

Interventions

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.

Papaverine group

Normal saline DRUG

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

Normal saline group

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with kidney cancer.
• Patients undergoing robot assisted partial nephrectomy under general anesthesia
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan medical Center

Seoul, 05505, South Korea

Location

MeSH Terms

Conditions

Kidney Neoplasms

Interventions

Papaverine; Saline Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Benzylisoquinolines; Alkaloids; Heterocyclic Compounds; Opiate Alkaloids; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Young-Kug Kim, MD,PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 10, 2019
• First Posted: November 14, 2019
• Study Start: November 21, 2019
• Primary Completion: April 15, 2021
• Study Completion: April 15, 2021
• Last Updated: April 19, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)