NCT02271191

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2012

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 15, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 22, 2014

Completed
Last Updated

October 23, 2014

Status Verified

October 1, 2014

Enrollment Period

8 months

First QC Date

October 15, 2014

Last Update Submit

October 21, 2014

Conditions

Spinal Stenosis

Outcome Measures

Primary Outcomes (4)

  • creatinine clearance

    after deliberate hypotension, and POD1

  • serum cystatin C

    before deliberate hypotension, after deliberate hypotension, and POD1

  • urine output

    after deliberate hypotension, and POD1

  • fractional excretion of sodium

    before deliberate hypotension, after deliberate hypotension, and POD1

Secondary Outcomes (1)

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

    before deliberate hypotension, after deliberate hypotension, and POD1

Study Arms (2)

Nicardipine and Remifentanil

ACTIVE COMPARATOR

intravenous nicardipine and remifentanil during deliberate hypotension

Drug: Nicardipine

Remifentanil

PLACEBO COMPARATOR

intravenous remifentanil during deliberate hypotension

Drug: Nicardipine

Interventions

NicardipineDRUG

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

Also known as: Perdipine
Nicardipine and RemifentanilRemifentanil

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing anterior or posterior spine interbody fusion

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Spinal Stenosis

Interventions

Nicardipine

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • 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 CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2014

First Posted

October 22, 2014

Study Start

May 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

October 23, 2014

Record last verified: 2014-10