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Anesthesia, GeneralPhase 3NCT05615025

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

A Phase 3 study testing Sevoflurane and Propofol in people with Anesthesia, General and Neuromuscular Transmission Disorders, run by Brugmann University Hospital at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Sevoflurane and Propofol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteBelgium
Study dates
20 Jan 2023to 7 Jul 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Language barrier
  • Any patient which will receive unplanned neuromuscular blocking agents during surgery
  • Any history of personal or familial suspected malignant hyperthermia

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • CHU Brugmann

    Brussels, 1020

Other trials in Belgium

About this study

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

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.

Being tested
Sevoflurane, Propofol
Medical subject headings
Neuromuscular Junction Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SevofluraneDrug

    Anesthesia will be maintained by sevoflurane.

  • PropofolDrug

    Anesthesia will be maintained by propofol.

Study groups in NCT05615025
Study groupRoleWhat they receive
Sevoflurane armExperimentalIn this arm, anesthesia will be maintained by sevoflurane.
Receives: Drug: Sevoflurane
Propofol armExperimentalIn this arm, anesthesia will be maintained by propofol.
Receives: Drug: Propofol

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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.

    Measured: 3 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2022
  2. Study start20 Jan 2023
  3. Primary completion30 Jun 2023
  4. Study completion7 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05615025
Sponsor's protocol ID
CHUB-ITF sevo-propofol
Status last verified
Jul 2023
First submitted
7 Nov 2022
Last updated
10 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sevoflurane and Propofol in people with Anesthesia, General and Neuromuscular Transmission Disorders, run by Brugmann University Hospital at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum force at the adductor pollicis (time frame: 3 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05615025, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2023.

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