Effect of Papaverine on Renal Artery Blood Flow Volume

NCT ID: NCT04162834

Last Updated: 2021-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-21

Study Completion Date

2021-04-15

Brief Summary

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

Detailed Description

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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.

Conditions

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Kidney Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Papaverine

Intervention Type 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.

Normal saline group

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

Group Type ACTIVE_COMPARATOR

Normal saline

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Normal saline

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Young-Kug Kim, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Young-Kug Kim, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Asan medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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20191111

Identifier Type: -

Identifier Source: org_study_id

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