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Can we Antagonize Mivacurium With Neostigmine ?

Primary Purpose

Mivacurium, Neostigmine, Residual Paralysis

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Neostigmine (40 mcg / kg) at different time of neuromuscular block's recovery
Spontaneous recovery
Sponsored by
Université Libre de Bruxelles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Mivacurium focused on measuring mivacurium, neostigmine, antagonism

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Michel Baurain

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

GROUP 1

GROUP 2

GROUP 3

GROUP 4

CONTROL

Arm Description

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)

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)

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)

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)

A control group : not receiving an antagonist (spontaneous recovery)

Outcomes

Primary Outcome Measures

Change in TOF ( Train Of Four) measure

Secondary Outcome Measures

Full Information

First Posted
December 22, 2016
Last Updated
May 17, 2017
Sponsor
Université Libre de Bruxelles
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1. Study Identification

Unique Protocol Identification Number
NCT03019835
Brief Title
Can we Antagonize Mivacurium With Neostigmine ?
Official Title
Can we Antagonize Mivacurium With Neostigmine
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
December 2016 (undefined)
Primary Completion Date
April 22, 2017 (Actual)
Study Completion Date
April 22, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université Libre de Bruxelles

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mivacurium, Neostigmine, Residual Paralysis
Keywords
mivacurium, neostigmine, antagonism

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GROUP 1
Arm Type
Active Comparator
Arm Description
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)
Arm Title
GROUP 2
Arm Type
Active Comparator
Arm Description
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)
Arm Title
GROUP 3
Arm Type
Active Comparator
Arm Description
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)
Arm Title
GROUP 4
Arm Type
Active Comparator
Arm Description
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)
Arm Title
CONTROL
Arm Type
Active Comparator
Arm Description
A control group : not receiving an antagonist (spontaneous recovery)
Intervention Type
Drug
Intervention Name(s)
Neostigmine (40 mcg / kg) at different time of neuromuscular block's recovery
Intervention Type
Other
Intervention Name(s)
Spontaneous recovery
Intervention Description
just measuring the Train Of Four at 3 6 9 12 and 15 minutes and measure the Train Of Four Ratio
Primary Outcome Measure Information:
Title
Change in TOF ( Train Of Four) measure
Time Frame
for each patient, measure of Train Of Four at 3, 6, 9, 12, 15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Michel Baurain
City
Bruxelles Capitale
ZIP/Postal Code
1070
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
7880668
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.
Results Reference
result
PubMed Identifier
16183681
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.
Results Reference
result
PubMed Identifier
10719950
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.
Results Reference
result
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.ncbi.nlm.nih.gov/pubmed/7880668

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Can we Antagonize Mivacurium With Neostigmine ?

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