Effect of Nicardipine on Renal Function in Deliberate Hypotension

Study Overview
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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.

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.

Official Title
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Effect of Nicardipine on Renal Function in Deliberate Hypotension

Conditions
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Spinal Stenosis

Intervention / Treatment
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* Drug: Nicardipine


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nicardipine and Remifentanil<br>intravenous nicardipine and remifentanil during deliberate hypotension | Drug: Nicardipine<br>* nicardipine 1-5 ug/kg/min and remifentanil 0.05 ug/kg/min during deliberate hypotension in spine surgery<br>* Other names: Perdipine;|
| Placebo Comparator: Remifentanil<br>intravenous remifentanil during deliberate hypotension | Drug: Nicardipine<br>* nicardipine 1-5 ug/kg/min and remifentanil 0.05 ug/kg/min during deliberate hypotension in spine surgery<br>* Other names: Perdipine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| creatinine clearance |  | after deliberate hypotension, and POD1 | 
| serum cystatin C |  | before deliberate hypotension, after deliberate hypotension, and POD1 | 
| urine output |  | after deliberate hypotension, and POD1 | 
| fractional excretion of sodium |  | before deliberate hypotension, after deliberate hypotension, and POD1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk, injury, failure, loss, and end stage renal disease (RIFLE) criteria |  | before deliberate hypotension, after deliberate hypotension, and POD1 |