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Effect of Nicardipine on Renal Function in Deliberate Hypotension

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ClinicalTrials.gov Identifier: NCT02271191
Recruitment Status : Completed
First Posted : October 22, 2014
Last Update Posted : October 23, 2014
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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.

Condition or disease Intervention/treatment Phase
Spinal Stenosis Drug: Nicardipine Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Nicardipine on Renal Function in Deliberate Hypotension
Study Start Date : May 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Nicardipine and Remifentanil
intravenous nicardipine and remifentanil during deliberate hypotension
Drug: Nicardipine
nicardipine 1-5 ug/kg/min and remifentanil 0.05 ug/kg/min during deliberate hypotension in spine surgery
Other Name: Perdipine

Placebo Comparator: Remifentanil
intravenous remifentanil during deliberate hypotension
Drug: Nicardipine
nicardipine 1-5 ug/kg/min and remifentanil 0.05 ug/kg/min during deliberate hypotension in spine surgery
Other Name: Perdipine




Primary Outcome Measures :
  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 Outcome Measures :
  1. Risk, injury, failure, loss, and end stage renal disease (RIFLE) criteria [ Time Frame: before deliberate hypotension, after deliberate hypotension, and POD1 ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02271191


Sponsors and Collaborators
Yonsei University
Investigators
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Study Chair: Chul Ho Chang, MD, PhD 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

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02271191     History of Changes
Other Study ID Numbers: 6-2011-0205
First Posted: October 22, 2014    Key Record Dates
Last Update Posted: October 23, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
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Hypotension
Spinal Stenosis
Vascular Diseases
Cardiovascular Diseases
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Remifentanil
Nicardipine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Vasodilator Agents