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

NCT ID: NCT03600454

Last Updated: 2020-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2019-12-30

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.

Conditions

Muscle Weakness; Anesthesia; Anesthesia, Local; Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Hip surgery: spinal anesthesia

Patients scheduled to undergo elective total hip arthroplasty will receive spinal anesthesia in combination with monitored anesthesia care (MAC).

Group Type: EXPERIMENTAL

Spinal anesthesia

Intervention Type: 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

Hip surgery: general anesthesia

Patients scheduled to undergo elective total hip arthroplasty will receive general anesthesia

Group Type: EXPERIMENTAL

General anesthesia

Intervention Type: DRUG

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

Colectomy: general anesthesia and epidural analgesia

Patients scheduled to undergo elective laparoscopic hemicolectomy will receive general anesthesia combined with epidural analgesia (EA).

Group Type: EXPERIMENTAL

General anesthesia and epidural analgesia

Intervention Type: 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).

Colectomy: general anesthesia

Patients will receive general anesthesia.

Group Type: EXPERIMENTAL

General anesthesia

Intervention Type: DRUG

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

Interventions

General anesthesia

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

Intervention Type: DRUG

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

Intervention Type: DRUG

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).

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ziekenhuis Oost-Limburg

OTHER

Sponsor Role: lead

Responsible Party

Dimitri Dylst

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dimitri Dylst, MD

Role: PRINCIPAL_INVESTIGATOR

Ziekenhuis Oost-Limburg

Locations

Ziekenhuis Oost-Limburg

Genk, , Belgium

Countries

Belgium

References

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.

Reference Type: DERIVED

PMID: 37864209 (View on PubMed)

Other Identifiers

18/0010U

Identifier Type: -

Identifier Source: org_study_id