Effect of Nicardipine on Renal Function in Deliberate Hypotension

October 21, 2014 updated by: Yonsei University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Perdipine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
creatinine clearance
Time Frame: after deliberate hypotension, and POD1
after deliberate hypotension, and POD1
serum cystatin C
Time Frame: before deliberate hypotension, after deliberate hypotension, and POD1
before deliberate hypotension, after deliberate hypotension, and POD1
urine output
Time Frame: after deliberate hypotension, and POD1
after deliberate hypotension, and POD1
fractional excretion of sodium
Time Frame: before deliberate hypotension, after deliberate hypotension, and POD1
before deliberate hypotension, after deliberate hypotension, and POD1

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

October 15, 2014

First Submitted That Met QC Criteria

October 19, 2014

First Posted (Estimate)

October 22, 2014

Study Record Updates

Last Update Posted (Estimate)

October 23, 2014

Last Update Submitted That Met QC Criteria

October 21, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6-2011-0205

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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