Clinical trial NCT03019835: Can we Antagonize Mivacurium With Neostigmine ?
Official title: Can we Antagonize Mivacurium With Neostigmine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mivacurium
Neostigmine
Residual Paralysis
Keywords: mivacurium
neostigmine
antagonism
Lead sponsor: Université Libre de Bruxelles
Sponsor class: OTHER
First posted: 2017-01-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in TOF ( Train Of Four) measure
timeFrame: for each patient, measure of Train Of Four at 3, 6, 9, 12, 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Bruxelles Capitale
country: Belgium
facility: Michel Baurain
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.