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Effect of Nicardipine on Renal Function in Deliberate Hypotension

Primary Purpose

Spinal Stenosis

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Nicardipine

About this trial

This is an interventional prevention trial for Spinal Stenosis

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Nicardipine and Remifentanil

Remifentanil

Arm Description

intravenous nicardipine and remifentanil during deliberate hypotension

intravenous remifentanil during deliberate hypotension

Outcomes

Primary Outcome Measures

creatinine clearance

serum cystatin C

urine output

fractional excretion of sodium

Secondary Outcome Measures

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

Full Information

NCT ID

NCT02271191

First Posted

October 15, 2014

Last Updated

October 21, 2014

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT02271191

Brief Title

Effect of Nicardipine on Renal Function in Deliberate Hypotension

Official Title

Effect of Nicardipine on Renal Function in Deliberate Hypotension

Study Type

Interventional

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Completed

Study Start Date

May 2012 (undefined)

Primary Completion Date

January 2013 (Actual)

Study Completion Date

January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Stenosis

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nicardipine and Remifentanil

Arm Type

Active Comparator

Arm Description

intravenous nicardipine and remifentanil during deliberate hypotension

Arm Title

Remifentanil

Arm Type

Placebo Comparator

Arm Description

intravenous remifentanil during deliberate hypotension

Intervention Type

Drug

Intervention Name(s)

Nicardipine

Other Intervention Name(s)

Perdipine

Intervention Description

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

Primary Outcome Measure Information:

Title

creatinine clearance

Time Frame

after deliberate hypotension, and POD1

Title

serum cystatin C

Time Frame

before deliberate hypotension, after deliberate hypotension, and POD1

Title

urine output

Time Frame

after deliberate hypotension, and POD1

Title

fractional excretion of sodium

Time Frame

before deliberate hypotension, after deliberate hypotension, and POD1

Secondary Outcome Measure Information:

Title

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

Time Frame

before deliberate hypotension, after deliberate hypotension, and POD1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chul Ho Chang, MD, PhD

Organizational Affiliation

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

Official's Role

Study Chair

12. IPD Sharing Statement

Learn more about this trial

Effect of Nicardipine on Renal Function in Deliberate Hypotension

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