Effect of Nicardipine on Renal Function in Deliberate Hypotension

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02271191

Enrollment

Registered

2014-10-22

Start date

2012-05-31

Completion date

2013-01-31

Last updated

2014-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Stenosis

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.

Interventions

DRUGNicardipine

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Measure	Time frame
Risk, injury, failure, loss, and end stage renal disease (RIFLE) criteria	before deliberate hypotension, after deliberate hypotension, and POD1

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026