major surgery • off-pump coronary bypass surgery • on-pump coronary bypass surgery • Aortic Valve Replacement Mini Access Surgery • laparoscopic hemicolectomies • thoracoscopic lung resections • femoral popliteal and tibial bypass surgery • laparoscopic radical prostatectomies MedDRA version: 21.1 Level: PT Classification code 10042609 Term: Surgery System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Solu-medrol
Pharmaceutical Form: Concentrate and solvent for solution for injection/infusion
INN or Proposed INN: methylprednisolone
Other descriptive name: METHYLPREDNISOLONE
Concentratio
Sponsors
Ziekenhuis Oost-Limburg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Aged 60 years or older. - Scheduled for a complex major surgical procedure. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 270 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 404
Exclusion criteria
Exclusion criteria: - Lack of informed consent or inability to give informed consent. - Severe PONV, needing corticosteroids as PONV prophylaxis. - Urgent, not elective surgery - Hypersensitivity or known allergic reactions to methylprednisolone - Preoperative use of steroids: o Including, but not limited to, the use of corticosteroids > 4 weeks before surgery of at least 4 mg methylprednisolone equivalents. o Excluding inhalational 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.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Functional and clinical outcomes - Post-operative muscle function - Post-operative lung function - Cognitive status (S5Q) - Fatigue questionnaire (Chalder fatigue questionnaire) - QOR-15 scale - EQ5D - NRS pain score 0-10 - PONV - P/F ratio Biochemical analyses and markers of coagulation - Blood will be drawn for analysis ;Timepoint(s) of evaluation of this end point: Functional and clinical outcomes - Post-operative muscle function on day 3 and day 5 - Post-operative lung function on day 1, 3 and 5 - Cognitive status on day 1, 3 and 5 - Fatigue questionnaire on day 1, 3 and 5 - QOR-15 scale on day 1, 3 and 5. - EQ5D on day 28, as compared to pre-operatively values. - VAS pains score 0-100 preoperatively and postoperatively on 8hr and 18hr of each day up to day 3. - PONV on post-operative first day, yes-no on 08hr and 18hr - P/F ratio on day 1: lowest and highest value Biochemical analyses and markers of coagulation - three different time points: before induction, at the end of the operation and on post-operative day 1. | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this prospective trial is to evaluate the effect of moderate dose corticosteroids on early post-operative outcome, focusing on muscle weakness, in elderly patients (=60 years) undergoing complex major surgery.;Secondary Objective: We will also monitor secondary outcomes related to early recovery after surgery and we will investigate the effect on systemic inflammation and coagulation. functional and clinical outcomes biochemical analysis and markers of coagulation ;Primary end point(s): postoperative muscle strength;Timepoint(s) of evaluation of this end point: preoperative postoperative day 1 | — |
Countries
Belgium
Contacts
Public ContactPrincipal Investigator
Ziekenhuis Oost-Limburg
Outcome results
None listed