Effect of Nicardipine on Renal Function in Deliberate Hypotension
Information source: Yonsei University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
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
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.
Clinical Details
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 clearanceserum 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.
Eligibility
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
Locations and Contacts
Additional Information
Starting date: May 2012
Last updated: October 21, 2014
|