Skip to main content
OpenTrials
Completed

NCT Number: NCT03600454

The Effect of Anesthesia on Perioperative Muscle Weakness and Neuro-endocrine Stress Response

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

General anesthesia

Drug

The induction of general anesthesia will be delivered in a standardized manner with the intravenous administration of fentanyl 2µg/kg and propofol

spinal anesthesia

Drug

The level of puncture will be L4 - L5. 10 mg bupivacaine will be injected in the subarachnoid space, after spontaneous surge of cerebrospinal fluid

General anesthesia and epidural analgesia

Drug

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).

Primary outcomes

  1. Change in post-operative peripheral limb muscle weakness

    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

Secondary outcomes

  1. Change in general health status

    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)

  2. Change in post-operative lung function: vital capacity

    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).

  3. Change in post-operative lung function:forced expiratory volume

    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).

  4. Change in the neuro-endocrine stress response: Cortisol

    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

  5. Change in the neuro-endocrine stress response: ACTH

    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

  6. Change in the neuro-endocrine stress response: Noradrenaline

    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

  7. Change in glycemia levels

    Time frame: Pre-operative (Day 0), end of surgery and postoperatively (Day 1)

    Measurement of glycemia in the blood.

Sponsors and collaborators

Lead sponsor

Ziekenhuis Oost-Limburg

Other

Registry information

Acronym: MUSCLE

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 26, 2018
Registry last updated
Jan 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.