Overview

Effect of Methylprednisolone on Orthostatic Intolerance and Heart Rate Variability in Hip-arthroplasty Patients

Status:
Completed
Trial end date:
2017-01-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Rigshospitalet, Denmark
Collaborator:
Bispebjerg Hospital
Treatments:
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Criteria
Inclusion Criteria:

- Osteoarthrosis

- Undergoing total unilateral hip-arthroplasty surgery

- Speak and understand Danish

- Have given informed content

Exclusion Criteria:

- Revision or bilateral hip-arthroplasty surgery

- General anaesthesia

- Allergy or intolerance towards Methylprednisolone

- Local or systemic infection

- Permanent systemic treatment with steroids within 30 days peroperatively

- Insulin-dependent diabetes

- Atrial fibrillation

- Neurological disease incl. Parkinsons

- Daily use of hypnotics or sedatives

- Alcohol abuse >35 units per week

- Active treatment of ulcer within 3 months preoperatively

- Cancer disease

- Autoimmune disease incl. rheumatoid arthritis

- Pregnant or breast feeding women

- Menopause <1 year