Effect of Nicardipine on Renal Function in Deliberate Hypotension
- Registration Number
- NCT02271191
- Lead Sponsor
- Yonsei University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
- Patients undergoing anterior or posterior spine interbody fusion
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nicardipine and Remifentanil Nicardipine intravenous nicardipine and remifentanil during deliberate hypotension Remifentanil Nicardipine intravenous remifentanil during deliberate hypotension
- Primary Outcome Measures
Name Time Method urine output after deliberate hypotension, and POD1 creatinine clearance after deliberate hypotension, and POD1 serum cystatin C before deliberate hypotension, after deliberate hypotension, and POD1 fractional excretion of sodium before deliberate hypotension, after deliberate hypotension, and POD1
- Secondary Outcome Measures
Name Time Method Risk, injury, failure, loss, and end stage renal disease (RIFLE) criteria before deliberate hypotension, after deliberate hypotension, and POD1