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

Not Applicable

Completed

• Conditions: Anesthesia, Local; Anesthesia; Muscle Weakness; Surgery
• Interventions: Drug: General anesthesia; Drug: Spinal anesthesia; Drug: General anesthesia and epidural analgesia

• Registration Number: NCT03600454
• Lead Sponsor: Ziekenhuis Oost-Limburg

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.

Study Timeline

• Study First Submitted: 2018-06-14
• Study First Submitted QC: 2018-07-24
• Study First Posted: 2018-07-26
• Study Start: 2018-09-01
• Primary Completion: 2019-12-18
• Study Completion: 2019-12-30
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-06
• Last Update Posted: 2020-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hip surgery: general anesthesia	General anesthesia	Patients scheduled to undergo elective total hip arthroplasty will receive general anesthesia
Hip surgery: spinal anesthesia	Spinal anesthesia	Patients scheduled to undergo elective total hip arthroplasty will receive spinal anesthesia in combination with monitored anesthesia care (MAC).
Colectomy: general anesthesia	General anesthesia	Patients will receive general anesthesia.
Colectomy: general anesthesia and epidural analgesia	General anesthesia and epidural analgesia	Patients scheduled to undergo elective laparoscopic hemicolectomy will receive general anesthesia combined with epidural analgesia (EA).

Primary Outcome Measures

Name	Time	Method
Change in post-operative peripheral limb muscle weakness	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 Outcome Measures

Name	Time	Method
Change in post-operative lung function: vital capacity	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).
Change in the neuro-endocrine stress response: Cortisol	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
Change in the neuro-endocrine stress response: ACTH	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
Change in glycemia levels	Pre-operative (Day 0), end of surgery and postoperatively (Day 1)	Measurement of glycemia in the blood.
Change in general health status	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)
Change in post-operative lung function:forced expiratory volume	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).
Change in the neuro-endocrine stress response: Noradrenaline	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

Trial Locations

Locations (1)

Ziekenhuis Oost-Limburg; 🇧🇪 Genk, Belgium