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NCT Number: NCT02271191

Effect of Nicardipine on Renal Function in Deliberate Hypotension

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.

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Key information

Conditions

Spinal Stenosis Bone Diseases Musculoskeletal Diseases Spinal Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nicardipine

Drug

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

Other names: Perdipine

Primary outcomes

  1. creatinine clearance

    Time frame: after deliberate hypotension, and POD1

  2. serum cystatin C

    Time frame: before deliberate hypotension, after deliberate hypotension, and POD1

  3. urine output

    Time frame: after deliberate hypotension, and POD1

  4. fractional excretion of sodium

    Time frame: before deliberate hypotension, after deliberate hypotension, and POD1

Secondary outcomes

  1. Risk, injury, failure, loss, and end stage renal disease (RIFLE) criteria

    Time frame: before deliberate hypotension, after deliberate hypotension, and POD1

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 22, 2014
Registry last updated
Oct 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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