Effect of Preoperative Intravenous High Dose Methylprednisolone on Glucose Homeostasis in Patients Scheduled for Total Hip- and Knee-arthroplasty
Overview
- Phase
- Phase 3
- Intervention
- Methylprednisolone
- Conditions
- Osteoarthrosis
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 134
- Locations
- 1
- Primary Endpoint
- Changes in plasma blood glucose from baseline (before surgery) to 48 hours after surgery
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
This study evaluates the pathophysiological effects of a single dose of Methylprednisolone administered prior to total hip- and knee-arthroplasty surgery. The investigators examine the effect on blood glucose homeostasis.
Half of participants will receive intravenous Solu-Medrol 125 mg, while the other half will receive placebo.
The investigators hypothesize that the glucose homeostasis remains equally stable in the group receiving Methylprednisolone as in the group receiving placebo.
Detailed Description
The anti-inflammatory effects of glucocorticoids are well known. The beneficial effects on postoperative pain, postoperative nausea and vomiting are well-documented. Glucocorticoid might change the glucose metabolism as it induces insulin-resistance. Glucocorticoids are known to reduce the insulin-mediated glucose uptake by reducing the muscle glycogen synthase activity. The effect of a single high dose of glucocorticoid is poorly described in the literature, and therefore calls for further investigation. This study is embedded in a primary study registrated as: NCT02319343 For further details please view the EudraCT registration: EudraCT nr.: 2014-003395-23
Investigators
Viktoria Oline Lindberg-Larsen
MD, research assistant
Rigshospitalet, Denmark
Eligibility Criteria
Inclusion Criteria
- •Osteoarthrosis
- •Undergoing total unilateral hip- or knee arthroplasty surgery
- •Speak and understand Danish
- •Have given informed consent
Exclusion Criteria
- •Revision or bilateral hip- or knee-arthroplasty surgery
- •General anaesthesia
- •Allergy or intolerance towards Methylprednisolone
- •Local or systemic infection
- •Permanent systemic treatment with steroids within 30 days preoperatively
- •Insulin-dependent diabetes
- •Active treatment of ulcer within 3 months preoperatively
- •Cancer disease
- •Autoimmune disease incl. rheumatoid arthritis
- •Pregnant or breast feeding women
Arms & Interventions
Methylprednisolone
Preoperative single high dose of Solu-Medrol 125 mg iv.
Intervention: Methylprednisolone
Isotonic Sodium Chloride
Preoperative single dose of isotonic Sodium Chloride
Intervention: Isotonic Sodium Chloride
Outcomes
Primary Outcomes
Changes in plasma blood glucose from baseline (before surgery) to 48 hours after surgery
Time Frame: baseline to 48 hours
Secondary Outcomes
- Changes in plasma C-peptide from baseline (before surgery) to 48 hours after surgery(baseline to 48 hours)