Perioperative Inflammatory Response Clinical Trial
Official title:
Perioperative HMG-CoA-Reductase-Inhibitors: A Pilot Study Assessing the Role of "Statin" Therapy and Perioperative Inflammatory Response in Patients Undergoing Major Orthopedic Surgery
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
Previous studies have reported activation of the body's immune system during the
perioperative period.1 Typically, this "stress response" is limited and goes unnoticed by
the patient and health care team. However, physiologic insults that occur during major
surgery may elicit a more pronounced response known as the systemic inflammatory response
syndrome (SIRS). Such a response is of great clinical consequence, as it is known to
significantly worsen perioperative morbidity and mortality.1 HMG Co-A Reductase Inhibitors
(hereafter identified by the common name, "the statins") are potent inhibitors of
cholesterol synthesis, and their role in the treatment of atherosclerosis and prevention of
coronary artery disease is well documented.2-5 Interestingly, data from animal studies have
shown that statins have unique anti-inflammatory properties that are independent of their
lipid lowering effects.6 Recently, statin therapy has been associated with a reduced
incidence of perioperative cardiovascular and neurologic complications in major vascular and
thoracic surgery patients as well as improved outcomes in patients experiencing acute
coronary syndrome (ACS).7-13 In all ACS patient populations studied, improvement in outcome
has been attributed to coronary plaque stabilization, presumably a result of statins
mitigating the local inflammatory response at the level of the coronary plaque.
The purpose of this study is to quantify the magnitude of perioperative inflammation during
major orthopedic spine surgery and determine whether statins alter this systemic physiologic
response.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05495750 -
Suprazygomatic Maxillary Nerve Block Effect on Systemic Inflammatory Response in Cleft Palate Surgeries
|
Phase 4 |