Effect of Nicardipine on Renal Function in Deliberate Hypotension

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

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2013-01-31

Brief Summary

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The aim of this study was to demonstrate the effect of nicardipine on renal function with creatinine clearance, serum cystatin C, urine output and fractional excretion of sodium during deliberate hypotension for spine surgery.

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Detailed Description

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To induce deliberate hypotension, pharmacological agents such as inhalation anesthetics, calcium channel blockers, beta-adrenergic blockers have been used alone or in combination. Nicardipine, classed as a calcium channel blocker, has a peripheral vasodilator effect via relaxation of smooth muscle fiber and sympathetic nerve inhibition. Nicardipine expands the renal artery and increases glomerular filtration rate. Previous studies reported the renal protective effect of nicardipine in cardiac surgery with cardiopulmonary bypass and robot-assisted laparoscopic surgery.

The aim of this study was to demonstrate the effect of nicardipine on renal function with creatinine clearance , serum cystatin C, urine output and fractional excretion of sodium during deliberate hypotension for spine surgery.

Conditions

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Spinal Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Nicardipine and Remifentanil

intravenous nicardipine and remifentanil during deliberate hypotension

Group Type ACTIVE_COMPARATOR

Nicardipine

Intervention Type DRUG

nicardipine 1-5 ug/kg/min and remifentanil 0.05 ug/kg/min during deliberate hypotension in spine surgery

Remifentanil

intravenous remifentanil during deliberate hypotension

Group Type PLACEBO_COMPARATOR

Nicardipine

Intervention Type DRUG

nicardipine 1-5 ug/kg/min and remifentanil 0.05 ug/kg/min during deliberate hypotension in spine surgery

Interventions

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Nicardipine

nicardipine 1-5 ug/kg/min and remifentanil 0.05 ug/kg/min during deliberate hypotension in spine surgery

Intervention Type DRUG

Other Intervention Names

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Perdipine

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing anterior or posterior spine interbody fusion

Exclusion Criteria

* Patients with American Society of Anesthesiologists physical status III or IV
* Liver dysfunction with aspartate transaminase/alanine transaminase greater than 60/60 IU/L
* Cerebrovascular disease
* Anemia of less than hematocrit 24%
* Diabetes mellitus
* Severe malnutrition
* those diuretics or antihypertensive drugs

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chul Ho Chang, MD, PhD

Role: STUDY_CHAIR

Department of Anesthesiology and Pain Medicine, Gangnam Severance Hospital, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, 211 Eonju-ro, Gangnam-gu, Seoul 135-720, Republic of Korea