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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN51508868

Enrollment

100

Registered

2011-11-09

Start date

2011-10-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-operative muscle weakness, fatigue and inflammation Musculoskeletal Diseases Other specified disorders of muscle

Interventions

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 nec

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All elderly (male or female, aged > 60 years) elective abdominal surgery patients

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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.	—

Countries

Belgium

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026