Ziekenhuis Oost Limburg
Genk, Belgium
Not yet recruiting
Study of methylprednisolone effects on recovery after major surgery in elderly patients aged 60 and over
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What is this trial about?
A plain-language summary of the goals, design and what participants do
This clinical trial studies the effects of corticosteroids in elderly patients undergoing major surgery. The surgical procedures include robotic assisted laparoscopic radical prostatectomy, peripheral vascular surgery, coronary bypass surgery, thoracoscopic lung resection, laparoscopic colorectal surgery, and valve repair or replacement surgery. The study aims to evaluate how moderate doses of corticosteroids affect early recovery after these complex surgical procedures, with a particular focus on muscle weakness.
The treatment involves the use of methylprednisolone (Solu-Medrol), which is given through an intravenous injection. Patients will also receive sodium chloride solution (normal saline) as part of their treatment. The medication will be administered as a single dose on the day of surgery.
During the study, various aspects of recovery will be monitored, including muscle strength, lung function, pain levels, and overall quality of recovery. The study specifically focuses on patients who are 60 years of age or older, as this age group may have different recovery patterns and needs after major surgery.
The research process
The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
9 criteria
- You must be 60 years of age or older
- You must be scheduled for one of these major surgical procedures:
- Robotic prostate removal surgery (robotic assisted laparoscopic radical prostatectomies)
- Leg blood vessel surgery (peripheral vascular surgery)
- Heart bypass surgery with heart-lung machine (on pump coronary bypass)
- Heart bypass surgery without heart-lung machine (off pump coronary bypass)
- Minimally invasive lung surgery (thoracoscopic lung resection)
- Minimally invasive colon or rectal surgery (laparoscopic colorectal surgery)
- Minimally invasive heart valve surgery (valve repair or replacement)
- Both men and women can participate
Who cannot join the trial?
16 criteria
- Patients under 60 years of age cannot participate in the study
- Patients who are not scheduled for one of these major surgeries:
- Robotic prostate removal surgery (robotic assisted laparoscopic radical prostatectomy)
- Leg blood vessel surgery (peripheral vascular surgery)
- Heart bypass surgery (both on-pump and off-pump coronary bypass)
- Minimally invasive lung surgery (thoracoscopic lung resection)
- Minimally invasive colon and rectum surgery (laparoscopic colorectal surgery)
- Minimally invasive heart valve repair or replacement
- Patients who are currently participating in other clinical trials
- Patients who have had major surgery within the last 30 days
- Patients who are currently taking steroid medications or have taken them in the past 3 months
- Patients with severe muscle weakness or neuromuscular disorders
- Patients with severe heart, liver, or kidney problems
- Patients with uncontrolled diabetes
- Patients with active infections
- Patients who are pregnant or breastfeeding
- Patients who cannot provide informed consent
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Investigated drugs
Corticosteroids are medications that mimic the effects of hormones that your body naturally produces. In this trial, they are being studied to help elderly patients recover after major surgery. These medications can help reduce inflammation and support the body's stress response during and after surgical procedures. They may be particularly beneficial in preventing muscle weakness that often occurs after major operations in older patients.
What is already known about the treatment
Corticosteroids – A class of steroid medications administered before and during major surgery to potentially improve post-operative outcomes, particularly in elderly patients. These medications are typically given intravenously during the perioperative period and work by reducing inflammation and modulating the body's stress response to surgery. Corticosteroids function by binding to specific receptors in cells, suppressing inflammatory mediators and affecting various metabolic processes, which may help prevent post-operative complications and muscle weakness. These medications belong to the glucocorticoid class of drugs and are well-established in medical practice, being used in various surgical procedures including robotic, cardiac, and laparoscopic surgeries.
Investigated diseases
Based on the provided data, I will describe the relevant medical conditions that may occur after major surgeries:
Post-operative Muscle Weakness - A condition where patients experience reduced muscle strength following surgery. It commonly affects elderly patients after major operations and can impact mobility and daily activities. The condition typically develops shortly after surgery and may affect various muscle groups throughout the body.
Post-operative Fatigue Syndrome - A state of physical and mental exhaustion that occurs after major surgical procedures. Patients experience persistent tiredness, reduced energy levels, and difficulty performing routine tasks. This condition can last for several weeks after surgery.
Post-operative Cognitive Dysfunction - A temporary decline in cognitive function that can occur after major surgery, particularly in elderly patients. It affects memory, attention, and information processing abilities. The condition may present as confusion, difficulty concentrating, or problems with short-term memory.
Post-operative Nausea and Vomiting (PONV) - A common condition where patients experience feelings of sickness and vomiting after surgical procedures. It typically begins within the first 24 hours after surgery. The symptoms can range from mild to severe.
Post-operative Respiratory Dysfunction - A condition affecting lung function after major surgery. Patients may experience reduced breathing capacity and efficiency. It commonly manifests as shallow breathing or difficulty taking deep breaths.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517602-28-00Estimated enrolment674 patientsSponsorZiekenhuis Oost Limburg
sourced from the EU Clinical Trials Register and site verification
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