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

• Register: ISRCTN
• Last refreshed on: 12 February 2013
• Main ID: ISRCTN51508868
• Date of registration: 09/11/2011
• Primary sponsor: Vrije University Brussels [Vrije Universiteit Brussel] (Belgium)
• Public title: The effect of peri-operative anti-inflammatory treatment on postoperative muscle weakness and muscle fatigue in elderly elective surgery patients N/A
• Scientific title: The effect of peri-operative anti-inflammatory treatment on postoperative muscle weakness and muscle fatigue in elderly elective surgery patients: a double blinded randomized placebo-controlled trial
• Date of first enrolment: Oct 1 2011
• Target sample size: N=100 (N=25 per treatment arm)
• Recruitment status: Ongoing/Recruiting
• URL: http://isrctn.org/ISRCTN51508868
• Study type: Interventional
• Study design: Double blinded randomised placebo-controlled trial

Countries of recruitment

Belgium

Contacts

• Name: Ivan Bautmans

Key inclusion & exclusion criteria

Inclusion criteria: All elderly (male or female, aged > 60 years) elective abdominal surgery patients
Exclusion criteria: 1. Unavailable one day before the surgical intervention
2. Presenting important inflammation preoperatively C-reactive protein (CRP)>10mg/L
3. Unable to understand or execute the test instructions due to cognitive impairment mini mental state examination (MMSE<23 / 30) and/or physical disability
4. Already using selective tumor necrosis factor (TNF)-alpha inhibitors, nitric oxide donors, fibrates, non-steroidal anti-inflammatory drugs (NSAID?s) or corticosteroids or when contra-indications for the use of one of these products exist

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Post-operative muscle weakness, fatigue and inflammation

Intervention(s)

Three different pharmacological interventions, each counter-acting different steps of the inflammation-induced proteolytic pathway in skeletal muscle, will be compared to placebo control:
1. Tumor necrosis factor-alpha (TNF-a) inhibitor [50mg Etanercept by subcutaneous (SC) injection 1 day preoperative, N=25)
2. Calpain inhibitor (16mg Molsidomine daily by mouth (per os), starting 1 day preoperative until 1 week postoperative, N=25)
3. Nuclear factor kappa-light-chain-enhancer of activated B cells (NF-eB) downregulator (267mg Fenofibrate daily, starting 1 day preoperative until 1 week postoperative N=25)
4. Placebo control (N=25)

Primary Outcome(s)

1. Muscle performance: Maximal handgrip strength, muscle fatigue resistance and grip work will be assessed one day before surgery, and 2, 4, 8 and 30 days post-surgery
2. Self-perceived fatigue and pain: self-perceived fatigue (Fatigue subscale of the Profile of Mood State) and pain (Visual Analogue Scale) will be assessed one day before surgery, and 2, 4, 8 and 30 days post-surgery
3. Inflammation: circulating levels of pro- and anti-inflammatory cytokines and their intra-cellular gene expression in Peripheral Mononuclear Blood Cells. Overnight fasting serum samples will be collected from the non-dominant arm at one day before surgery, and 2, 4, 8 and 30 days post-surgery.

Secondary Outcome(s)

Occurrence of adverse reactions and postoperative complications:
All participants will be questioned and monitored for adverse reactions (potentially related to the study medication, i.e. allergies, headache, hypotension) at day 2, 4, 8 and 30 post-surgery.

Occurrence of postoperative complications will be extracted from the patient?s medical record.

Secondary ID(s)

N/A

Source(s) of Monetary Support

1. University of Brussels (Belgium) 2. Brussels University Hospital (Belgium)

Secondary Sponsor(s)

N/A