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Effect of Nicardipine on Renal Function in Deliberate Hypotension

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Yonsei University

Status and phase

Completed
Phase 4

Conditions

Spinal Stenosis

Treatments

Drug: Nicardipine

Study type

Interventional

Funder types

Other

Identifiers

NCT02271191
6-2011-0205

Details and patient eligibility

About

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.

Full 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.

Enrollment

64 patients

Sex

All

Ages

20+ years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

64 participants in 2 patient groups, including a placebo group

Nicardipine and Remifentanil
Active Comparator group
Description:
intravenous nicardipine and remifentanil during deliberate hypotension
Treatment:
Drug: Nicardipine
Remifentanil
Placebo Comparator group
Description:
intravenous remifentanil during deliberate hypotension
Treatment:
Drug: Nicardipine

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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