Effect of Nicardipine on Renal Function in Deliberate Hypotension

Condition(s) targeted: Spinal Stenosis

Intervention: Nicardipine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Yonsei University

Official(s) and/or principal investigator(s):
Chul Ho Chang, MD, PhD, Study Chair, Affiliation: 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

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: Effect of Nicardipine on Renal Function in Deliberate Hypotension

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome:

creatinine clearance

serum cystatin C

urine output

fractional excretion of sodium

Secondary outcome: Risk, injury, failure, loss, and end stage renal disease (RIFLE) criteria

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.

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Starting date: May 2012
Last updated: October 21, 2014