Ziekenhuis Oost-Limburg
Genk, 3600, Belgium
NCT Number: NCT03600454
The effect of surgery, in contrary to critical illness, on muscle weakness hasn't been thoroughly investigated. Recent data suggest that elective surgery may also induce muscle weakness. The neuro-endocrine stress response could be involved in the pathophysiology. Whether the mode of anesthesia/analgesia can influence muscle weakness, by influencing the neuro-endocrine stress response is unknown. Gaining insight in this matter could affect quality of care and benefit patient recovery and satisfaction.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Genk, 3600, Belgium
In this study, the investigators want to demonstrate whether the application of neuraxial anesthesia for elective surgery diminishes perioperative muscle weakness. Since spinal and epidural anesthesia/analgesia have been shown to influence the neuro-endocrine stress response, the possible underlying mediator of perioperative muscle weakness, the investigators will perform two different, but complementary, studies. In one study, patients scheduled for elective total hip arthroplasty will receive spinal anesthesia, without losing consciousness and maintaining a free airway, as compared to receiving general anesthesia. In another study, patients scheduled for a laparoscopic hemicolectomy will receive epidural anesthesia/analgesia during and after the surgery as compared to receiving no epidural anesthesia/analgesia. These studies allow the investigators to identify whether the application of neuraxial anesthesia/analgesia could diminish perioperative weakness and allow us to identify other possible mediators of perioperative muscle weakness, such as losing consciousness or receiving neuromuscular blockade.
This study has the potential to help to identify a new side-effect of elective surgery, namely perioperative muscle weakness, and to identify a possible treatment for this possible new complication, namely neuraxial anesthesia and analgesia, which might benefit many patients in the future. Furthermore, investigating the possible mediating role of the neuro-endocrine stress response might identify new therapeutic targets, such as glucagon modulation.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The induction of general anesthesia will be delivered in a standardized manner with the intravenous administration of fentanyl 2µg/kg and propofol
The level of puncture will be L4 - L5. 10 mg bupivacaine will be injected in the subarachnoid space, after spontaneous surge of cerebrospinal fluid
The induction of general anesthesia will be delivered in a standardized manner with the intravenous administration of fentanyl 2 µg/kg and propofol. A thoracic epidural catheter will be placed with 3 ml of xylocaine 2% (with epinephrine 1/200.000).
Time frame: Pre-operative (Day 0) and postoperatively (Day 1, Day 7 and Day 28)
The strength will be measured in the dominant hand using a Camry handgrip Dynamometer. The measurement will take place on the first day postoperatively, at day 7 and day 28 and will be compared to the preoperative measurement during the preoperative assessment
Time frame: Pre-operative (Day 0) and postoperatively (Day1, Day7 and Day28)
Measuring generic health status by the EQ-5D questionnaire preoperatively and at day 1, 7 and 28 after surgery. The general health status is scored by severity ranging from 0 (no problems) to 5 (severe problems)
Time frame: Pre-operative (Day 0) and postoperatively (Day 1, Day 7 and Day 28)
Post-operative lung function at day 1, 7 and 28. The investigators will measure vital capacity (VC). These measurements will take place preoperatively and day 1, 7 and 28 after surgery, using a portable pulmonary function testing machine (PPFTM).
Time frame: Pre-operative (Day 0) and postoperatively (Day 1, Day 7 and Day 28)
Post-operative lung function at day 1, 7 and 28. The investigators will measure forced expiratory volume in 1 second (FEV1). These measurements will take place preoperatively and day 1, 7 and 28 after surgery, using a portable pulmonary function testing machine (PPFTM).
Time frame: Pre-operative (Day 0), end of surgery and postoperatively (Day 1)
Blood samples will be taken at the start, end of surgery and the day after surgery to measure cortisol (nmol/L) in the samples
Time frame: Pre-operative (Day 0), end of surgery and postoperatively (Day 1)
Blood samples will be taken at the start, end of surgery and the day after surgery to measure ACTH (nmol/L) in the samples
Time frame: Pre-operative (Day 0), end of surgery and postoperatively (Day 1)
Blood samples will be taken at the start, end of surgery and the day after surgery to measure noradrenaline (nmol/L) in the samples
Time frame: Pre-operative (Day 0), end of surgery and postoperatively (Day 1)
Measurement of glycemia in the blood.
Ziekenhuis Oost-Limburg
Other
Acronym: MUSCLE
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