Clinical trial NCT03600454: The Effect of Anesthesia on Perioperative Muscle Weakness and Neuro-endocrine Stress Response
Official title: The Effect of Anesthesia on Perioperative Muscle Weakness and Neuro-endocrine Stress Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Weakness
Anesthesia
Anesthesia, Local
Surgery
Lead sponsor: Ziekenhuis Oost-Limburg
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two independent, but complimentary, studies will be performed to evaluate the primary objective and the secondary objectives in this prospective trail.

Group 1: The effect of spinal anesthesia as compared to general anesthesia for total hip arthroplasty

Group 2: The effect of epidural analgesia compared to general anesthesia alone for major abdominal surgery
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older.
* Scheduled for elective total hip arthroplasty or hemicolectomy.

Exclusion Criteria:

* Lack of informed consent or inability to give informed consent.
* Urgent surgery, such as hip fracture.
* Contra-indications for spinal or epidural analgesia, including but not limited to:

  * Infection at the site of puncture.
  * Coagulopathy.
  * Severe hypovolemia.
  * Severe aortic valve stenosis (cross sectional area \< 1,3 cm2).
  * Severe mitralis valve stenosis (cross sectional area \< 1,0 cm2).
  * Increased intracranial pressure.
  * Pre-existing neurological condition.
  * Severe spine deformity.
  * Sepsis.
  * Body mass index (BMI) \> 35 kg/m2
* Hypersensitivity or known allergic reactions to any products used for anesthesia.
* History of chronic opioid analgesics use.
* Preoperative use of steroids:

  * Including, but not limited to: injection of hydrocortisone \< 3 months before surgery.
* Preexisting muscle disease

  * Including, but not limited to: Steinert's disease, amyotrophic lateral sclerosis (ALS), Duchenne dystrophy, amputation of dominant arm or hand.

Primary outcomes:
measure: Change in post-operative peripheral limb muscle weakness
timeFrame: Pre-operative (Day 0) and postoperatively (Day 1, Day 7 and Day 28)
Secondary outcomes:
measure: Change in general health status
timeFrame: Pre-operative (Day 0) and postoperatively (Day1, Day7 and Day28)
measure: Change in post-operative lung function: vital capacity
timeFrame: Pre-operative (Day 0) and postoperatively (Day 1, Day 7 and Day 28)
measure: Change in post-operative lung function:forced expiratory volume
timeFrame: Pre-operative (Day 0) and postoperatively (Day 1, Day 7 and Day 28)
measure: Change in the neuro-endocrine stress response: Cortisol
timeFrame: Pre-operative (Day 0), end of surgery and postoperatively (Day 1)
measure: Change in the neuro-endocrine stress response: ACTH
timeFrame: Pre-operative (Day 0), end of surgery and postoperatively (Day 1)
measure: Change in the neuro-endocrine stress response: Noradrenaline
timeFrame: Pre-operative (Day 0), end of surgery and postoperatively (Day 1)
measure: Change in glycemia levels
timeFrame: Pre-operative (Day 0), end of surgery and postoperatively (Day 1)
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
Study officials:
affiliation: Ziekenhuis Oost-Limburg
name: Dimitri Dylst, MD
role: PRINCIPAL_INVESTIGATOR
References: