Effect of Papaverine on Renal Artery Blood Flow Volume

Asan Medical Center

Status and phase: Completed; Phase 4

Conditions: Kidney Cancer

Treatments: Drug: Papaverine; Drug: Normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT04162834

20191111

Details and patient eligibility

About

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

Full 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.

Enrollment: 96 patients

Sex: All

Ages: 20 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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96 participants in 2 patient groups

Papaverine group

Experimental group

Description:

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.

Treatment:

Drug: Papaverine

Normal saline group

Active Comparator group

Description:

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

Treatment:

Drug: Normal saline