Major surgery induces a systemic inflammatory response, which can influence the post-operative morbidity, such as coagulation disorders and post-operative muscle weakness, hampering early recovery after surgery. Single administration of high dose corticosteroids is known to reduce this inflammatory response and could possibly improve the post-operative outcome. The CORTERAS study will evaluate the effect of administration of corticosteroids, as compared to no corticosteroids, on postoperative muscle weakness and quality of recovery after surgery in elderly patients.
The number of elderly patients undergoing surgery is expected to increase in the coming years, due to the increase in life expectancy in the developing world. Compared to younger surgical patients, the older patients are at greater risk of mortality and morbidity after surgery. Post-operative fatigue is an important complication after surgery. Not only is it reported by patients as one of the most distressing symptoms, it is also thought to be a significant contributor to delayed recovery after surgery. From a pathophysiological point of view, muscle weakness could be a major contributor to this post-operative fatigue. Recent studies showed a profound reduction in muscle strength after surgery in elderly patients, which lasted for more than 3 months after surgery. This decrease in muscle strength might be induced by an excessive inflammatory response to surgery. Glucocorticosteroids are capable of tampering an excessive inflammatory response to surgery and could improve the quality of recovery after surgery. However, a possible effect on post-operative muscle weakness hasn't been specifically investigated. Therefore, the main objective of this prospective clinical trial is to evaluate the effect of corticosteroids on early post-operative outcome, focusing on muscle weakness, in elderly patients (≥60 years) undergoing surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
751
250 mg Methylprednisolone made up with 100 ml NaCl0,9% as an IV injection at the induction of anaesthesia but before surgery. If CPB is required an additional dose in 100 ml will be given.
100 ml NaCl0,9% as an IV injection at the induction of anaesthesia but before surgery. If CPB is required an additional 100ml will be given.
Ziekenhuis Oost-Limburg
Genk, Belgium
Post operative muscle weakness
decrease in muscle strength post-operatively, assessed by comparing the handgrip strength of the dominant hand, measured by the JAMAR dynamometer, on day 1 following surgery as compared to the preoperative value
Time frame: Pre-operative and Post operative day 1
Post operative muscle weakness
Decrease in muscle strength post-operatively, assessed by comparing the handgrip strength of the dominant hand, measured by the JAMAR dynamometer, on day 3 and 5 following surgery as compared to the preoperative value, if still in the hospital.
Time frame: Pre-operative and Post operative day 1, 3 and 5
Maximum inspiratory pressure as measure of respiratory muscle function
Maximum inspiratory pressure on day 1, 3 and 5, as compared to pre-operative value, if still in the hospital.
Time frame: Pre-operative and Post operative day 1, 3 and 5
Post operative fatigue
Assessed by the Chalder fatigue Questionnaire - 11 items, scores min 0 - max 33, higher score means worse outcome: post-operative day 1, 3, 5 and 28, as compared to preoperatively
Time frame: Pre-operative and Post operative day 1, 3, 5 and 28
Quality of recovery (QOR)
Assessed by the QOR-15 scale, scores min 0 - max 150, higher score means worse outcome, assessed on day 1, 3 and 5 as compared to preoperatively
Time frame: Post operative day 1, 3 and 5
Functioning at day 28
EuroQol five dimensions of health (EQ5D), score of 1-5 on each health dimension, higher score means worse outcome + visual analogue scale from 0-100 questionning todays health, lower score means worse outcome. EQ5D is assessed on day 28, as compared to pre-operatively values
Time frame: Pre-operative and Post operative day 28
Coagulation disorder
biochemical markers of coagulation postoperatively as compared to preoperatively
Time frame: postoperatively first 24 hours
Sleeping pattern
Assessed by the Consensus Sleep Diary (CSD) in a subset of study population
Time frame: 10 consecutive nights, starting 3 days before surgery
Sleep quality
Assessed by the Pittsburgh Sleep Quality Index (PSQI) in a subet of study population, score range between 0 and 21, higher scores indicate worse sleep quality
Time frame: 3 days before and 10 days after surgery
Sleep chronotype
Assessed by the Munich Chronotype Questionnaire (MCTQ) is a subset of study population
Time frame: 3 days before surgery
Sleeping EEG pattern
Assessed by EEG recording in a subset of study population
Time frame: first postoperative night
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