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Assessing the Role of "Statin" Therapy and Perioperative Inflammatory Response in Patients Undergoing Major Orthopedic Surgery

NCT00656292 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2017-05-19

Study results available
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Summary

The purpose of the present study is to quantify the degree of modulation, if any, in the perioperative inflammatory response associated with statins use. Specifically, we hypothesize that:

In a population of patients undergoing elective orthopedic spine surgery, administration of a specific statin (Simvastatin, Zocor®, Merck Pharmaceuticals), will be associated with a decrease in perioperative inflammatory markers when compared to patients not taking statins

Conditions

  • Perioperative Inflammatory Response

Interventions

DRUG

Simvastatin

40 mg po/nasogastric tube (NG) every day for 6 days

DRUG

Placebo

1 pill po/NG every day x 6 days

Sponsors & Collaborators

Principal Investigators

  • Michael J. Brown, M.D. · Mayo Clinic Department of Anesthesiology

  • Daryl Kor, M.D. · Mayo Clinic Department of Anesthesiolgy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2016-03-31
Completion
2016-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00656292 on ClinicalTrials.gov