CORTERAS STUDY: The Effect of Corticosteroids on Early Recovery After Major Surgery in Elderly Patients

• Status: Not yet recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Major surgery induces a systemic inflammatory response, which can influence the post-operative morbidity, such as coagulation disorders and post-operative muscle weakness, hampering early recovery after surgery.

Single administration of high dose corticosteroids is known to reduce this inflammatory response and could possibly improve the post-operative outcome.

The CORTERAS study will evaluate the effect of administration of corticosteroids, as compared to no corticosteroids, on postoperative muscle weakness and quality of recovery after surgery in elderly patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ziekenhuis Oost-Limburg
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

• Aged 60 years or older.

• Scheduled for one of the predefined surgical procedures:

• off-pump coronary bypass surgery

• on-pump coronary bypass surgery

• aortic valve replacement

• laparoscopic hemicolectomies

• thoracoscopic lung resections

• femoral popliteal and tibial bypass surgery

• laparoscopic radical prostatectomies

Exclusion Criteria:

• Lack of informed consent or inability to give informed consent.

• Severe postoperative nausea & vomiting (PONV), needing corticosteroids as PONV prophylaxis.

• Urgent, not elective surgery

• Hypersensitivity or known allergic reactions to methylprednisolone

• Preoperative systemic use of steroids:

• Including, but not limited to, the use of corticosteroids > 4 weeks before surgery of at least 4 mg methylprednisolone equivalents.

• Excluding inhalational and topical steroids

• Preexisting muscle disease o Including, but not limited to: Steinert's disease, amyotrophic lateral sclerosis (ALS), Duchenne dystrophy, amputation of dominant arm or hand.