Study Results
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Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2016-12-31
2017-04-22
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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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)
Neostigmine (40 mcg / kg) at different time of neuromuscular block's recovery
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)
Neostigmine (40 mcg / kg) at different time of neuromuscular block's recovery
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)
Neostigmine (40 mcg / kg) at different time of neuromuscular block's recovery
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)
Neostigmine (40 mcg / kg) at different time of neuromuscular block's recovery
CONTROL
A control group : not receiving an antagonist (spontaneous recovery)
Spontaneous recovery
just measuring the Train Of Four at 3 6 9 12 and 15 minutes and measure the Train Of Four Ratio
Interventions
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Neostigmine (40 mcg / kg) at different time of neuromuscular block's recovery
Spontaneous recovery
just measuring the Train Of Four at 3 6 9 12 and 15 minutes and measure the Train Of Four Ratio
Eligibility Criteria
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Inclusion Criteria
* Absence of neuromuscular disease, renal and hepatic insufficiency
* Absence of medication that could interfere with the mediators of the neuromuscular junction
Exclusion Criteria
* Parkinson disease
* BMI\> 35
* Known hypersensitivity to neostigmine or to any of the excipients of Neostigmine
18 Years
75 Years
ALL
No
Sponsors
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Université Libre de Bruxelles
OTHER
Responsible Party
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JOHN NICOLARDOT
MD
Locations
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Michel Baurain
Bruxelles Capitale, , Belgium
Countries
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References
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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.
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.
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.
Study Documents
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Document Type: Study Protocol
View DocumentOther Identifiers
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U1111-1190-7993
Identifier Type: OTHER
Identifier Source: secondary_id
B406201629996
Identifier Type: -
Identifier Source: org_study_id
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