CClinicalTrials.gg
CompletedNCT03019835Updated May 19, 2017

Can we Antagonize Mivacurium With Neostigmine ?

An interventional study of Neostigmine (40 mcg / kg) at different time of neuromuscular block's recovery and Spontaneous recovery in Mivacurium, Neostigmine and Residual Paralysis, sponsored by Université Libre de Bruxelles. Completed at 1 site in Belgium. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-05-19.

Sponsored by Université Libre de Bruxelles · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The antagonism of neuromuscular blocking agents (NMBA) (or curares), as well as the antagonism of other drugs used in anesthesia, is a major challenge for the speciality.

Residual paralysis is indeed a risk factor for post-operative morbidity and mortality and antagonization of curares at the end of the procedure is associated with a reduction in mortality .

Its use should be as large as possible and its contraindications are extremely rare.

The antagonism of the NMBA reduces the duration of the neuromuscular block and the complications that are associated .

In this study, the investigators use mivacurium (or Mivacron) as non-depolarizing curare and neostigmine as an antagonist.

Neostigmine reduces the duration of the neuromuscular block induced by mivacurium, By reducing the breakdown of acetylcholine, neostigmine induces an increase in acetylcholine in the synaptic cleft which competes for the same binding site as nondepolarizing neuromuscular blocking agents, and reverses the neuromuscular blockade.

But the use of neostigmine in current practice is not very widespread in this clinical situation.

The reduction in the duration of the block is significant in comparison with a spontaneous recovery .

Moreover, spontaneous recovery is not always complete and sometimes very long.

Nevertheless, its action is effective and this study could support this use but also specify the duration and the quality of the return to normal of the neuromuscular transmission.

02

Conditions studied

  • Mivacurium
  • Neostigmine
  • Residual Paralysis

Browse trials for

Keywords

  • mivacurium
  • neostigmine
  • antagonism
03

In context

Paralysis

750 studies on the registry are indexed under Paralysis; 133 are open to participants now.

This study's enrollment of 80 is above the median of 30 across 537 interventional studies indexed under Paralysis.

Browse Paralysis studies →

Lead sponsor

Université Libre de Bruxelles is the lead sponsor of 44 studies on the registry; 13 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients American Society of Anesthesiologists (ASA) 1 to 3
  • Absence of neuromuscular disease, renal and hepatic insufficiency
  • Absence of medication that could interfere with the mediators of the neuromuscular junction

Exclusion criteria

Exclusion Criteria:

  • Bronchial asthma
  • Parkinson disease
  • BMI> 35
  • Known hypersensitivity to neostigmine or to any of the excipients of Neostigmine
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
80 participants (actual)

Study arms

  • Active comparator
    GROUP 1

    A group receiving neostigmine (40 mcg / kg) when the block Neuromuscular block's recovery measured by acceleromyography is 1 response of 4 in TOF mode (Train Of Four)

    Drug: Neostigmine (40 mcg / kg) at different time of neuromuscular block's recovery

  • Active comparator
    GROUP 2

    A group receiving neostigmine (40 mcg / kg) when the block Neuromuscular block's recovery measured by acceleromyography is 2 response of 4 in TOF mode (Train Of Four)

    Drug: Neostigmine (40 mcg / kg) at different time of neuromuscular block's recovery

  • Active comparator
    GROUP 3

    A group receiving neostigmine (40 mcg / kg) when the block Neuromuscular block's recovery measured by acceleromyography is 3 response of 4 in TOF mode (Train Of Four)

    Drug: Neostigmine (40 mcg / kg) at different time of neuromuscular block's recovery

  • Active comparator
    GROUP 4

    A group receiving neostigmine (40 mcg / kg) when the block Neuromuscular block's recovery measured by acceleromyography is 4 response of 4 in TOF mode (Train Of Four)

    Drug: Neostigmine (40 mcg / kg) at different time of neuromuscular block's recovery

  • Active comparator
    CONTROL

    A control group : not receiving an antagonist (spontaneous recovery)

    Other: Spontaneous recovery

Interventions

  • DrugNeostigmine (40 mcg / kg) at different time of neuromuscular block's recovery
  • OtherSpontaneous recovery

    just measuring the Train Of Four at 3 6 9 12 and 15 minutes and measure the Train Of Four Ratio

06

What researchers measure

Primary outcomes

  1. Change in TOF ( Train Of Four) measure

    Time frame: for each patient, measure of Train Of Four at 3, 6, 9, 12, 15 minutes

07

Study locations

1 site
  • Michel Baurain
    Bruxelles Capitale, 1070, Belgium
08

References and documents

Publications

  • Baurain MJ, Dernovoi BS, d'Hollander AA, Hennart DA. Comparison of neostigmine-induced recovery with spontaneous recovery from mivacurium-induced neuromuscular block. Br J Anaesth. 1994 Dec;73(6):791-4. doi: 10.1093/bja/73.6.791. PubMed 7880668 ↗
  • Baillard C, Clec'h C, Catineau J, Salhi F, Gehan G, Cupa M, Samama CM. Postoperative residual neuromuscular block: a survey of management. Br J Anaesth. 2005 Nov;95(5):622-6. doi: 10.1093/bja/aei240. Epub 2005 Sep 23. PubMed 16183681 ↗
  • Szenohradszky J, Fogarty D, Kirkegaard-Nielsen H, Brown R, Sharma ML, Fisher DM. Effect of edrophonium and neostigmine on the pharmacokinetics and neuromuscular effects of mivacurium. Anesthesiology. 2000 Mar;92(3):708-14. doi: 10.1097/00000542-200003000-00015. PubMed 10719950 ↗

Individual participant data

Plan to share: Yes

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 19, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03019835
Lead sponsor
Université Libre de Bruxelles
Responsible party
JOHN NICOLARDOT (MD, Université Libre de Bruxelles) — Principal investigator
First posted
Jan 13, 2017
Start date
Dec 2016
Primary completion
Apr 22, 2017
Completion
Apr 22, 2017
Last update
May 19, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion