Clinical trial NCT05615025: Influence of Sevoflurane and Propofol on Maximum Muscular Strength, Speed of Contraction and Relaxation
Official title: Influence of Sevoflurane and Propofol on Maximum Muscular Strength, Speed of Contraction and Relaxation, in Humans: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anesthesia, General
Neuromuscular Transmission Disorders
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Many drugs have an influence on neuromuscular transmission. In clinical practice, neuromuscular blocking agents are commonly used, but even in the absence of neuromuscular blocking agents, anesthetic drugs can influence neuromuscular transmission. Especially volatile anesthetic agents have a clinical impact on neuromuscular transmission, they have been shown to prolong and deepen the effect of neuromuscular blocking agents. But even in the absence of neuromuscular blocking agents, volatile anesthetics can impair neuromuscular transmission. One mechanism of action is the desensitization of the acetylcholine receptors by shifting them from a normal to a desensitized state. This effect can weaken neuromuscular transmission by reducing the margin of safety that normally exists at the neuromuscular junction, or can cause an apparent increase in the capacity of neuromuscular blocking agents to block transmission.

In this study, the influence of sevoflurane and propofol on the maximum force, maximum speed of contraction and relaxation will be measured at the adductor pollicis in patients having general anesthesia without the use of neuromuscular blocking agents. Maximum force and speed of contraction and relaxation will be measured before and after anesthesia by either sevoflurane or propofol. Primary outcome is the influence of either anesthetic agent on maximum muscular force and speed of contraction - relaxation, and if this influence is greater for volatile anesthetic agents than for intravenous anesthetic agents.


Eligibility criteria: Inclusion criteria

* Patients (male or female) from 18 - 80 years
* Scheduled for surgery without the use of neuromuscular blocking agents
* Health care insurance in Belgium
* Written informed consent

Exclusion Criteria:

* Any pathology involving neuromuscular transmission
* Confirmed neuropathy of any origin
* Expected anesthesia duration \< 30 min
* Renal insufficiency defined as a glomerular filtration rate \< 40 mL/min/m2
* Hepatic insufficiency defined as an increase \> 1.5 \* normal value of hepatic enzymes
* Confirmed or suspected pregnancy
* Language barrier
* Any patient which will receive unplanned neuromuscular blocking agents during surgery
* Any history of personal or familial suspected malignant hyperthermia

Primary outcomes:
measure: Maximum force at the adductor pollicis
timeFrame: 3 hours
measure: Maximum speed of contraction at the adductor pollicis
timeFrame: 3 hours
measure: Maximum speed of relaxation at the adductor pollicis
timeFrame: 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann
Study officials:
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