Can we Antagonize Mivacurium With Neostigmine ?

NCT ID: NCT03019835

Last Updated: 2017-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2017-04-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mivacurium Neostigmine Residual Paralysis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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)

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

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)

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

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)

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

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)

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

CONTROL

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

Group Type ACTIVE_COMPARATOR

Spontaneous recovery

Intervention Type OTHER

just measuring the Train Of Four at 3 6 9 12 and 15 minutes and measure the Train Of Four Ratio

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DRUG

Spontaneous recovery

just measuring the Train Of Four at 3 6 9 12 and 15 minutes and measure the Train Of Four Ratio

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Université Libre de Bruxelles

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

JOHN NICOLARDOT

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Michel Baurain

Bruxelles Capitale, , Belgium

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 7880668 (View on PubMed)

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.

Reference Type RESULT
PMID: 16183681 (View on PubMed)

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.

Reference Type RESULT
PMID: 10719950 (View on PubMed)

Study Documents

Access uploaded study-related documents such as protocols, statistical analysis plans, or lay summaries.

Document Type: Study Protocol

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

U1111-1190-7993

Identifier Type: OTHER

Identifier Source: secondary_id

B406201629996

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Motor-Sparing Femoral Nerve Block Dose
NCT02909257 TERMINATED PHASE4