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

NCT03600454 | Completed

• 1 other identifier: 18/0010U
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscle Weakness; Anesthesia; Anesthesia, Local; Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change in general health status

  Pre-operative (Day 0) and postoperatively (Day1, Day7 and Day28)

• Change in post-operative lung function: vital capacity

  Pre-operative (Day 0) and postoperatively (Day 1, Day 7 and Day 28)

• Change in post-operative lung function:forced expiratory volume

  Pre-operative (Day 0) and postoperatively (Day 1, Day 7 and Day 28)

• Change in the neuro-endocrine stress response: Cortisol

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

• Change in the neuro-endocrine stress response: ACTH

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

Study Arms (4)

Hip surgery: spinal anesthesia

EXPERIMENTAL

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

Drug: Spinal anesthesia

Hip surgery: general anesthesia

EXPERIMENTAL

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

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).

Drug: General anesthesia and epidural analgesia

Colectomy: general anesthesia

EXPERIMENTAL

Patients will receive general anesthesia.

Drug: General anesthesia

Interventions

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

Colectomy: general anesthesia; Hip surgery: general anesthesia

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

Hip surgery: spinal anesthesia

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).

Colectomy: general anesthesia and epidural analgesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years or older.
• Scheduled for elective total hip arthroplasty or hemicolectomy.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ziekenhuis Oost-Limburg: lead

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

Location

Related Publications (1)

• 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.

  PMID: 37864209 DERIVED

MeSH Terms

Conditions

Muscle Weakness

Interventions

Anesthesia, General; Anesthesia, Spinal; Analgesia, Epidural

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Anesthesia, Conduction; Analgesia

Study Officials

• Dimitri Dylst, MD

  Ziekenhuis Oost-Limburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Patients will be randomized using a computer-generated permuted block randomization sequence (variable block-size, 1:1 allocation). The randomization will be determined on the preoperative anesthesia assessment. After the randomisation, the investigator will inform the patient which anesthesia he/she will get during the operation
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: June 14, 2018
• First Posted: July 26, 2018
• Study Start: September 1, 2018
• Primary Completion: December 18, 2019
• Study Completion: December 30, 2019
• Last Updated: January 7, 2020

Record last verified: 2020-01

Locations

BE (1)