Muscle WeaknessMUSCLENCT03600454
The Effect of Anesthesia on Perioperative Muscle Weakness and Neuro-endocrine Stress Response
A study testing General anesthesia, Spinal anesthesia and General anesthesia and epidural analgesia in people with Muscle Weakness and Anesthesia, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle Weakness, Anesthesia, Anesthesia, Local
- What is being tested?
- General anesthesia, Spinal anesthesia and General anesthesia and epidural analgesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2018to 30 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older.
- Scheduled for elective total hip arthroplasty or hemicolectomy.
Who cannot join
- 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.
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Muscle Weakness, Anesthesia, Anesthesia, Local, Surgery
- Being tested
- General anesthesia, Spinal anesthesia, General anesthesia and epidural analgesia
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General anesthesiaDrug
The induction of general anesthesia will be delivered in a standardized manner with the intravenous administration of fentanyl 2µg/kg and propofol
Spinal anesthesiaDrug
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 analgesiaDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| Hip surgery: spinal anesthesia | Experimental | Patients scheduled to undergo elective total hip arthroplasty will receive spinal anesthesia in combination with monitored anesthesia care (MAC). Receives: Drug: Spinal anesthesia |
| Hip surgery: general anesthesia | Experimental | Patients scheduled to undergo elective total hip arthroplasty will receive general anesthesia Receives: Drug: General anesthesia |
| Colectomy: general anesthesia and epidural analgesia | Experimental | Patients scheduled to undergo elective laparoscopic hemicolectomy will receive general anesthesia combined with epidural analgesia (EA). Receives: Drug: General anesthesia and epidural analgesia |
| Colectomy: general anesthesia | Experimental | Patients will receive general anesthesia. Receives: Drug: General anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Pre-operative (Day 0) and postoperatively (Day 1, Day 7 and Day 28)
Secondary outcomes (7)
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)
Measured: Pre-operative (Day 0) and postoperatively (Day1, Day7 and Day28)
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).
Measured: Pre-operative (Day 0) and postoperatively (Day 1, Day 7 and Day 28)
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).
Measured: Pre-operative (Day 0) and postoperatively (Day 1, Day 7 and Day 28)
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
Measured: Pre-operative (Day 0), end of surgery and postoperatively (Day 1)
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
Measured: Pre-operative (Day 0), end of surgery and postoperatively (Day 1)
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
Measured: Pre-operative (Day 0), end of surgery and postoperatively (Day 1)
Change in glycemia levels
Measurement of glycemia in the blood.
Measured: Pre-operative (Day 0), end of surgery and postoperatively (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start1 Sep 2018
- Primary completion18 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle WeaknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ziekenhuis Oost-Limburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dimitri Dylst, Ziekenhuis Oost-Limburg
- Investigators
- Dimitri Dylst, MD, Principal investigator, Ziekenhuis Oost-Limburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03600454
- Sponsor's protocol ID
- 18/0010U
- Acronym
- MUSCLE
- Status last verified
- Jan 2020
- First submitted
- 14 Jun 2018
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Van Boxstael S, Peene L, Dylst D, Penders J, Hadzic A, Meex I, Corten K, Mesotten D, Thiessen S. The effect of spinal versus general anaesthesia on perioperative muscle weakness in patients having bilateral total hip arthroplasty: a single center randomized clinical trial. Eur J Med Res. 2023 Oct 20;28(1):450. doi: 10.1186/s40001-023-01435-6.
PubMed 37864209
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Anesthesia on Perioperative Muscle Weakness and Neuro-endocrine Stress Response
- ClinicalTrials.gov ID
- NCT03600454
- Acronym / sponsor ID
- MUSCLE / 18/0010U
- Conditions
- Muscle Weakness, Anesthesia, Anesthesia, Local, Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ziekenhuis Oost-LimburgUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 18 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
- 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
| Arm | Type | Receives |
|---|---|---|
| Hip surgery: spinal anesthesia | Experimental | Drug: Spinal anesthesiaPatients scheduled to undergo elective total hip arthroplasty will receive spinal anesthesia in combination with monitored anesthesia care (MAC). |
| Hip surgery: general anesthesia | Experimental | Drug: General anesthesiaPatients scheduled to undergo elective total hip arthroplasty will receive general anesthesia |
| Colectomy: general anesthesia and epidural analgesia | Experimental | Drug: General anesthesia and epidural analgesiaPatients scheduled to undergo elective laparoscopic hemicolectomy will receive general anesthesia combined with epidural analgesia (EA). |
| Colectomy: general anesthesia | Experimental | Drug: General anesthesiaPatients will receive general anesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged 18 years or older.
- Scheduled for elective total hip arthroplasty or hemicolectomy.
Key exclusion criteria (19 listed)
- 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:
- Hypersensitivity or known allergic reactions to any products used for anesthesia.
- History of chronic opioid analgesics use.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| General anesthesiaThe induction of general anesthesia will be delivered in a standardized manner with the intravenous administration of fentanyl 2µg/kg and propofol | Drug | Colectomy: general anesthesia, Hip surgery: general anesthesia |
| Spinal anesthesiaThe level of puncture will be L4 - L5. 10 mg bupivacaine will be injected in the subarachnoid space, after spontaneous surge of cerebrospinal fluid | Drug | Hip surgery: spinal anesthesia |
| General anesthesia and epidural analgesiaThe 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). | Drug | Colectomy: general anesthesia and epidural analgesia |
Primary outcome
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
7 secondary outcomes
Change in general health status
Time frame: Pre-operative (Day 0) and postoperatively (Day1, Day7 and Day28)
Change in post-operative lung function: vital capacity
Time frame: Pre-operative (Day 0) and postoperatively (Day 1, Day 7 and Day 28)
Change in post-operative lung function:forced expiratory volume
Time frame: Pre-operative (Day 0) and postoperatively (Day 1, Day 7 and Day 28)
Change in the neuro-endocrine stress response: Cortisol
Time frame: Pre-operative (Day 0), end of surgery and postoperatively (Day 1)
Change in the neuro-endocrine stress response: ACTH
Time frame: Pre-operative (Day 0), end of surgery and postoperatively (Day 1)
Change in the neuro-endocrine stress response: Noradrenaline
Time frame: Pre-operative (Day 0), end of surgery and postoperatively (Day 1)
Change in glycemia levels
Time frame: Pre-operative (Day 0), end of surgery and postoperatively (Day 1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
- Derived from this study: PubMed 37864209Van Boxstael S, Peene L, Dylst D, Penders J, Hadzic A, Meex I, Corten K, Mesotten D, Thiessen S. The effect of spinal versus general anaesthesia on perioperative muscle weakness in patients having bilateral total hip arthroplasty: a single center randomized clinical trial. Eur J Med Res. 2023 Oct 20;28(1):450. doi: 10.1186/s40001-023-01435-6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dimitri Dylst, MD principal investigator
Ziekenhuis Oost-Limburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing General anesthesia, Spinal anesthesia and General anesthesia and epidural analgesia in people with Muscle Weakness and Anesthesia, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in post-operative peripheral limb muscle weakness (time frame: Pre-operative (Day 0) and postoperatively (Day 1, Day 7 and Day 28)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03600454, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2020.