E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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
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E.1.1.1 | Medical condition in easily understood language |
major surgery (cardial, abdominal, vascular surgery)
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10042609 |
E.1.2 | Term | Surgery |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Aged 60 years or older. - Scheduled for a complex major surgical procedure.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
postoperative muscle strength |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
preoperative postoperative day 1 |
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E.5.2 | 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
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E.5.2.1 | 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.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Postoperative Day 28 of last enrolled subject |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |