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Completed

NCT Number: NCT03019835

Can we Antagonize Mivacurium With Neostigmine ?

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.

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Key information

Conditions

Mivacurium Neostigmine Residual Paralysis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Michel Baurain

Bruxelles Capitale, 1070, Belgium

Who can participate

Healthy volunteers accepted: No

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

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

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

Treatment and study plan

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

Drug

Spontaneous recovery

Other

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

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

Sponsors and collaborators

Lead sponsor

Université Libre de Bruxelles

Other

Registry information

Official study title

Can we Antagonize Mivacurium With Neostigmine

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 13, 2017
Registry last updated
May 19, 2017

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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