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

Surgery Clinical Trial

— MUSCLE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03600454
• Other study ID #: 18/0010U
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: December 30, 2019

Study information

• Verified date: January 2020
• Source: Ziekenhuis Oost-Limburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 30, 2019
• Est. primary completion date: December 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia
• Anesthesia, Local
• Muscle Weakness
• Paresis
• Surgery

Intervention

Drug:
• General anesthesia
The induction of general anesthesia will be delivered in a standardized manner with the intravenous administration of fentanyl 2µg/kg and propofol
• Spinal anesthesia
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
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).

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg	Genk

Sponsors (1)

Lead Sponsor	Collaborator
Ziekenhuis Oost-Limburg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in post-operative peripheral limb muscle weakness	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	Pre-operative (Day 0) and postoperatively (Day 1, Day 7 and Day 28)
Secondary	Change in general health status	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)	Pre-operative (Day 0) and postoperatively (Day1, Day7 and Day28)
Secondary	Change in post-operative lung function: vital capacity	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).	Pre-operative (Day 0) and postoperatively (Day 1, Day 7 and Day 28)
Secondary	Change in post-operative lung function:forced expiratory volume	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).	Pre-operative (Day 0) and postoperatively (Day 1, Day 7 and Day 28)
Secondary	Change in the neuro-endocrine stress response: Cortisol	Blood samples will be taken at the start, end of surgery and the day after surgery to measure cortisol (nmol/L) in the samples	Pre-operative (Day 0), end of surgery and postoperatively (Day 1)
Secondary	Change in the neuro-endocrine stress response: ACTH	Blood samples will be taken at the start, end of surgery and the day after surgery to measure ACTH (nmol/L) in the samples	Pre-operative (Day 0), end of surgery and postoperatively (Day 1)
Secondary	Change in the neuro-endocrine stress response: Noradrenaline	Blood samples will be taken at the start, end of surgery and the day after surgery to measure noradrenaline (nmol/L) in the samples	Pre-operative (Day 0), end of surgery and postoperatively (Day 1)
Secondary	Change in glycemia levels	Measurement of glycemia in the blood.	Pre-operative (Day 0), end of surgery and postoperatively (Day 1)