Effect of Nicardipine on Renal Function in Deliberate Hypotension

Spinal Stenosis Clinical Trial

Official title:

Effect of Nicardipine on Renal Function in Deliberate Hypotension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02271191
• Other study ID #: 6-2011-0205
• Status: Completed
• Phase: Phase 4
• First received: October 15, 2014
• Last updated: October 21, 2014
• Start date: May 2012
• Est. completion date: January 2013

Study information

• Verified date: October 2014
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypotension
• Spinal Stenosis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	creatinine clearance		after deliberate hypotension, and POD1	No
Primary	serum cystatin C		before deliberate hypotension, after deliberate hypotension, and POD1	No
Primary	urine output		after deliberate hypotension, and POD1	No
Primary	fractional excretion of sodium		before deliberate hypotension, after deliberate hypotension, and POD1	No
Secondary	Risk, injury, failure, loss, and end stage renal disease (RIFLE) criteria		before deliberate hypotension, after deliberate hypotension, and POD1	No