The effect of peri-operative anti-inflammatory treatment on postoperative muscle weakness and muscle fatigue in elderly surgery patients

Conditions: Post-operative muscle weakness, fatigue and inflammation.
Therapeutic area: Body processes [G] - Physiological processes [G07]

Registration Number: EUCTR2011-005534-19-BE

Lead Sponsor: Vrije Universiteit Brussel

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

All elderly (male or female, aged >60 years) elective abdominal surgery patients are eligible for participation.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

Patients will be excluded when unavailable 1 day before the surgical intervention; when presenting important inflammation pre-operatively (CRP>10mg/L); when being unable to understand or execute the test instructions due to cognitive impairment (MMSE<23/30) and/or physical disability; when already using selective TNF-alpha inhibitors, nitric oxide donors, fibrates, NSAID’s or corticosteroids or when contra-indications for the use of one of these products exist.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: In a double-blinded placebo-controlled RCT, we aim to evaluate the effectiveness of three different pharmacological interventions in elderly (age >60years) elective abdominal surgery patients in order to prevent inflammation-induced structural changes in the skeletal muscle to occur.;Secondary Objective: Identify the relationship between the effect of the interventions on muscle performance, fatigue and surgery-induced inflammation.;Primary end point(s): A) Maximal handgrip strength, muscle fatigue resistance and grip work<br>B) Self-perceived fatigue (Fatigue subscale of the Profile of Mood State) and pain (Visual Analogue Scale)<br>C)Circulating levels of pro- and anti-inflammatory cytokines and their intra-cellular gene expression in Peripheral Mononuclear Blood Cells.;Timepoint(s) of evaluation of this end point: one day before surgery, and 2, 4, 8 and 30 days post-surgery

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): All participants will be questioned and monitored for adverse reactions (potentially related to the study medication, i.e. allergies, headache, hypotension,…..). Occurrence of postoperative complications will be extracted from the patient’s medical record.;Timepoint(s) of evaluation of this end point: day 2, 4, 8 and 30 post-surgery