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CompletedNCT05615025Updated Jul 10, 2023

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

A Phase 3 interventional study of Sevoflurane and Propofol in Anesthesia, General and Neuromuscular Transmission Disorders, sponsored by Brugmann University Hospital. Completed at 1 site in Belgium. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-07-10.

Sponsored by Brugmann University Hospital · Phase 3, Interventional, and Basic science

Phase
Phase 3
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Anesthesia, General
  • Neuromuscular Transmission Disorders
03

In context

Lead sponsor

Brugmann University Hospital is the lead sponsor of 116 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    Sevoflurane arm

    In this arm, anesthesia will be maintained by sevoflurane.

    Drug: Sevoflurane

  • Experimental
    Propofol arm

    In this arm, anesthesia will be maintained by propofol.

    Drug: Propofol

Interventions

  • DrugSevoflurane

    Anesthesia will be maintained by sevoflurane.

  • DrugPropofol

    Anesthesia will be maintained by propofol.

06

What researchers measure

Primary outcomes

  1. Maximum force at the adductor pollicis

    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.

    Time frame: 3 hours

  2. Maximum speed of contraction at the adductor pollicis

    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.

    Time frame: 3 hours

  3. Maximum speed of relaxation at the adductor pollicis

    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.

    Time frame: 3 hours

07

Study locations

1 site
  • CHU Brugmann
    Brussels, 1020, Belgium
08

References and documents

Publications

  • Baurain MJ, Hoton F, D'Hollander AA, Cantraine FR. Is recovery of neuromuscular transmission complete after the use of neostigmine to antagonize block produced by rocuronium, vecuronium, atracurium and pancuronium? Br J Anaesth. 1996 Oct;77(4):496-9. doi: 10.1093/bja/77.4.496. PubMed 8942335 ↗
  • Chung F, Chan VW, Ong D. A post-anesthetic discharge scoring system for home readiness after ambulatory surgery. J Clin Anesth. 1995 Sep;7(6):500-6. doi: 10.1016/0952-8180(95)00130-a. PubMed 8534468 ↗
  • Debaene B, Frasca D, Moreillon F, D'Hollander AA. 100 Hz-5 s tetanic stimulation to illustrate the presence of "residual paralysis" co-existing with accelerometric 0.90 train-of-four ratio-A proof-of-concept study. Anaesth Crit Care Pain Med. 2021 Aug;40(4):100903. doi: 10.1016/j.accpm.2021.100903. Epub 2021 Jun 17. PubMed 34147687 ↗
  • Dubois PE, Mitchell J, Regnier M, Passeraub PA, Moreillon F, d'Hollander AA. The interest of 100 versus 200 Hz tetanic stimulations to quantify low levels of residual neuromuscular blockade with mechanomyography: a pilot study. J Clin Monit Comput. 2022 Aug;36(4):1131-1137. doi: 10.1007/s10877-021-00745-6. Epub 2021 Jul 24. PubMed 34302578 ↗
  • Feldman S, Karalliedde L. Drug interactions with neuromuscular blockers. Drug Saf. 1996 Oct;15(4):261-73. doi: 10.2165/00002018-199615040-00004. PubMed 8905251 ↗
  • Gage PW. Ion channels and postsynaptic potentials. Biophys Chem. 1988 Feb;29(1-2):95-101. doi: 10.1016/0301-4622(88)87028-5. PubMed 2451942 ↗
  • Karis JH, Gissen AJ, Nastuk WL. The effect of volatile anesthetic agents on neuromuscular transmission. Anesthesiology. 1967 Jan-Feb;28(1):128-34. doi: 10.1097/00000542-196701000-00014. No abstract available. PubMed 6017421 ↗
  • Ochiai R, Guthrie RD, Motoyama EK. Effects of varying concentrations of halothane on the activity of the genioglossus, intercostals, and diaphragm in cats: an electromyographic study. Anesthesiology. 1989 May;70(5):812-6. doi: 10.1097/00000542-198905000-00018. PubMed 2719316 ↗
  • Ochiai R, Guthrie RD, Motoyama EK. Differential sensitivity to halothane anesthesia of the genioglossus, intercostals, and diaphragm in kittens. Anesth Analg. 1992 Mar;74(3):338-44. doi: 10.1213/00000539-199203000-00004. PubMed 1539811 ↗
  • Pereda AE, Faber DS. Activity-dependent short-term enhancement of intercellular coupling. J Neurosci. 1996 Feb 1;16(3):983-92. doi: 10.1523/JNEUROSCI.16-03-00983.1996. PubMed 8558267 ↗
  • Raines DE. Anesthetic and nonanesthetic halogenated volatile compounds have dissimilar activities on nicotinic acetylcholine receptor desensitization kinetics. Anesthesiology. 1996 Mar;84(3):663-71. doi: 10.1097/00000542-199603000-00022. PubMed 8659795 ↗
  • Silverman DG, Brull SJ. The effect of a tetanic stimulus on the response to subsequent tetanic stimulation. Anesth Analg. 1993 Jun;76(6):1284-7. doi: 10.1213/00000539-199376060-00017. PubMed 8098919 ↗
  • Simons JC, Pierce E, Diaz-Gil D, Malviya SA, Meyer MJ, Timm FP, Stokholm JB, Rosow CE, Kacmarek RM, Eikermann M. Effects of Depth of Propofol and Sevoflurane Anesthesia on Upper Airway Collapsibility, Respiratory Genioglossus Activation, and Breathing in Healthy Volunteers. Anesthesiology. 2016 Sep;125(3):525-34. doi: 10.1097/ALN.0000000000001225. PubMed 27404221 ↗
  • Stauble CG, Stauble RB, Schaller SJ, Unterbuchner C, Fink H, Blobner M. Effects of single-shot and steady-state propofol anaesthesia on rocuronium dose-response relationship: a randomised trial. Acta Anaesthesiol Scand. 2015 Aug;59(7):902-11. doi: 10.1111/aas.12523. Epub 2015 May 12. PubMed 25962311 ↗
  • Tassonyi E, Charpantier E, Muller D, Dumont L, Bertrand D. The role of nicotinic acetylcholine receptors in the mechanisms of anesthesia. Brain Res Bull. 2002 Jan 15;57(2):133-50. doi: 10.1016/s0361-9230(01)00740-7. PubMed 11849819 ↗
  • Yamaoka K, Vogel SM, Seyama I. Na+ channel pharmacology and molecular mechanisms of gating. Curr Pharm Des. 2006;12(4):429-42. doi: 10.2174/138161206775474468. PubMed 16472137 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05615025
Lead sponsor
Brugmann University Hospital
Responsible party
Denis SCHMARTZ (Anesthesiologists, Université Libre de Bruxelles) — Principal investigator
First posted
Nov 14, 2022
Start date
Jan 20, 2023
Primary completion
Jun 30, 2023
Completion
Jul 7, 2023
Last update
Jul 10, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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