Can we Antagonize Mivacurium With Neostigmine ?

Neostigmine Clinical Trial

Official title:

Can we Antagonize Mivacurium With Neostigmine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03019835
• Other study ID #: B406201629996
• Secondary ID: U1111-1190-7993
• Status: Completed
• Phase: N/A
• First received: December 22, 2016
• Last updated: May 17, 2017
• Start date: December 2016
• Est. completion date: April 22, 2017

Study information

• Verified date: May 2017
• Source: Université Libre de Bruxelles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 22, 2017
• Est. primary completion date: April 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Mivacurium
• Neostigmine
• Paralysis
• Residual Paralysis

Intervention

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

Other:
• Spontaneous recovery
just measuring the Train Of Four at 3 6 9 12 and 15 minutes and measure the Train Of Four Ratio

Locations

Country	Name	City	State
Belgium	Michel Baurain	Bruxelles Capitale

Sponsors (1)

Lead Sponsor	Collaborator
Université Libre de Bruxelles

Country where clinical trial is conducted

Belgium, 

References & Publications (3)

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. Epub 2005 Sep 23. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in TOF ( Train Of Four) measure		for each patient, measure of Train Of Four at 3, 6, 9, 12, 15 minutes