Can we Antagonize Mivacurium With Neostigmine ?
2 other identifiers
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 22, 2016
CompletedFirst Posted
Study publicly available on registry
January 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 22, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 22, 2017
CompletedMay 19, 2017
May 1, 2017
5 months
December 22, 2016
May 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in TOF ( Train Of Four) measure
for each patient, measure of Train Of Four at 3, 6, 9, 12, 15 minutes
Study Arms (5)
GROUP 1
ACTIVE COMPARATORA 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)
GROUP 2
ACTIVE COMPARATORA 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)
GROUP 3
ACTIVE COMPARATORA 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)
GROUP 4
ACTIVE COMPARATORA 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)
CONTROL
ACTIVE COMPARATORA control group : not receiving an antagonist (spontaneous recovery)
Interventions
just measuring the Train Of Four at 3 6 9 12 and 15 minutes and measure the Train Of Four Ratio
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Bronchial asthma
- Parkinson disease
- BMI\> 35
- Known hypersensitivity to neostigmine or to any of the excipients of Neostigmine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Michel Baurain
Bruxelles Capitale, 1070, Belgium
Related Publications (3)
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.
PMID: 7880668RESULTBaillard 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.
PMID: 16183681RESULTSzenohradszky 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.
PMID: 10719950RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
December 22, 2016
First Posted
January 13, 2017
Study Start
December 1, 2016
Primary Completion
April 22, 2017
Study Completion
April 22, 2017
Last Updated
May 19, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will share