Can we Antagonize Mivacurium With Neostigmine ?

May 17, 2017 updated by: JOHN NICOLARDOT, Université Libre de Bruxelles

Can we Antagonize Mivacurium With Neostigmine

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles Capitale, Belgium, 1070
        • Michel Baurain

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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)
Drug: Neostigmine (40 mcg / kg) at different time of neuromuscular block's recovery
Active Comparator: 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)
Drug: Neostigmine (40 mcg / kg) at different time of neuromuscular block's recovery
Active Comparator: 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)
Drug: Neostigmine (40 mcg / kg) at different time of neuromuscular block's recovery
Active Comparator: 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)
Drug: Neostigmine (40 mcg / kg) at different time of neuromuscular block's recovery
Active Comparator: CONTROL
A control group : not receiving an antagonist (spontaneous 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in TOF ( Train Of Four) measure
Time Frame: for each patient, measure of Train Of Four at 3, 6, 9, 12, 15 minutes
for each patient, measure of Train Of Four at 3, 6, 9, 12, 15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université Libre de Bruxelles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Actual)

April 22, 2017

Study Completion (Actual)

April 22, 2017

Study Registration Dates

First Submitted

December 22, 2016

First Submitted That Met QC Criteria

January 12, 2017

First Posted (Estimate)

January 13, 2017

Study Record Updates

Last Update Posted (Actual)

May 19, 2017

Last Update Submitted That Met QC Criteria

May 17, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B406201629996
  • U1111-1190-7993 (Other Identifier: WHO-UTN)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Study Data/Documents

  1. Study Protocol

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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