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NCT Number: NCT05615025

Influence of Sevoflurane and Propofol on Maximum Muscular Strength, Speed of Contraction and Relaxation

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.

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Key information

Conditions

Anesthesia, General Nervous System Diseases Neuromuscular Diseases Neuromuscular Junction Diseases Neuromuscular Transmission Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU Brugmann

Brussels, 1020, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sevoflurane

Drug

Anesthesia will be maintained by sevoflurane.

Propofol

Drug

Anesthesia will be maintained by propofol.

Primary outcomes

  1. Maximum force at the adductor pollicis

    Time frame: 3 hours

    Maximum force developed by a voluntary contraction of the adductor pollicis will be measured during isometric contraction. Maximum force developped before and after anesthesia will be compared. The difference in force (Newton) will be measured.

  2. Maximum speed of contraction at the adductor pollicis

    Time frame: 3 hours

    Maximum speed of contraction developed by a voluntary contraction of the adductor pollicis will be measured during isometric contraction. Maximum speed of contraction developped before and after anesthesia will be compared. The difference in force (Newton/seconds) will be measured.

  3. Maximum speed of relaxation at the adductor pollicis

    Time frame: 3 hours

    Maximum speed of relaxation developed by a voluntary contraction of the adductor pollicis will be measured during isometric contraction. Maximum speed of relaxation developped before and after anesthesia will be compared. The difference in force (Newton/seconds) will be measured.

Sponsors and collaborators

Lead sponsor

Brugmann University Hospital

Other

Registry information

Official study title

Influence of Sevoflurane and Propofol on Maximum Muscular Strength, Speed of Contraction and Relaxation, in Humans: A Pilot Study

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 14, 2022
Registry last updated
Jul 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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