Study of methylprednisolone effects on recovery after major surgery in elderly patients aged 60 and over

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What is this study about?

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.

1 Initial preparation

You will be scheduled for a major surgery procedure, which may include one of the following: robotic prostate surgery, vascular surgery, heart bypass surgery, lung surgery, colorectal surgery, or heart valve surgery.

Before the surgery, your medical condition and eligibility will be confirmed. You must be 60 years or older to participate in this study.

2 Medication administration

You will receive two medications through an intravenous line (a thin tube inserted into your vein):

The first medication is Solu-Medrol (methylprednisolone), which is a corticosteroid given by injection

The second medication is sodium chloride solution (salt water) given by infusion

3 Assessments during recovery

Your recovery will be monitored through several measurements:

Assessment of muscle strength and function

Evaluation of breathing capacity

Completion of questionnaires about your mental status

Rating of your fatigue levels

Assessment of your pain levels using a scale from 0 to 10

Monitoring for any feelings of nausea or vomiting

Blood tests to check various health markers

4 Quality of life evaluation

You will complete questionnaires about:

Your overall recovery experience

Your general health and well-being

Your daily activities and comfort levels

Who Can Join the Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Ziekenhuis Oost Limburg Genk Belgium

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not yet recruiting
01.04.2022

Trial locations

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.

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 ID:
2024-517602-28-00
NCT ID:
NCT05220319
Trial Phase:
Therapeutic confirmatory (Phase III)

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