Osteoarthrosis Clinical Trial
Official title:
Effect of Preoperative Intravenous High Dose Methylprednisolone on Orthostatic Intolerance and Heart Rate Variability in Patients Scheduled for Total Hip-arthroplasty
The study evaluates the pathophysiological effects of a single dose Methylprednisolone
administered prior to total hip-arthroplasty (THA) surgery. The investigators examine the
effect on orthostatic intolerance, orthostatic hypotension and heart rate variability (HRV)
to evaluate the efficacy of Methylprednisolone regarding blood pressure regulation and
autonomic responses after THA.
Half of participants will receive intravenous Solu-Medrol 125 mg, while the other half will
receive placebo.
The investigators hypothesize that the group receiving Methylprednisolone will be less
orthostatic intolerant, experience less orthostatic hypotension and have an improved
autonomic response compared to the placebo-group, early after THA.
The anti-inflammatory effects of glucocorticoids are well known. The beneficial effects in
postoperative pain, postoperative nausea and vomiting are well-documented.
Hip-arthroplasty surgery and the inflammatory stress response in general affect the
potential of recovery. Early postoperative orthostatic intolerance is common in patients
undergoing THA with an incidence of 40%. The mechanism is thought related to an impaired
autonomic regulation caused by surgery-induced inflammation. The effect of glucocorticoids
on orthostatic intolerance, orthostatic hypotension and HRV after hip-arthroplasty surgery
is unknown and calls for further investigation.
The study is to be considered as exploratory. The primary analysis of the primary outcome
measure is a comparison of the incidence of orthostatic intolerance from baseline to 6 hours
postoperatively between the two groups.
For calculation of sample size the difference in incidence between groups (40% versus 10%)
from baseline (before surgery) to 6 hours after THA-surgery, a risk of type I errors 5% and
a risk of type II errors 20% (80% power) were used.
The primary analysis is carried out on all included patients (intention-to-treat) with
baseline values as covariate. Secondary exploratory per-protocol analysis might be
performed. Missing outcomes will be analysed using multiple imputation due to expected
strong time trends.
The secondary outcomes measures; Non-invasive blood pressure, systemic vascular resistance,
cardiac output, HRV, plasma-hemoglobin, C-reactive protein.
For further details please also view the European Clinical Trials Database (EudraCT)
registration:
EudraCT nr.: 2015-000102-19
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