Can we Antagonize Mivacurium With Neostigmine ?

Sponsor
Université Libre de Bruxelles (Other)
Overall Status
Completed
CT.gov ID
NCT03019835
Collaborator
(none)
80
1
5
4.7
17.1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Neostigmine (40 mcg / kg) at different time of neuromuscular block's recovery
  • Other: Spontaneous recovery
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Other
Official Title:
Can we Antagonize Mivacurium With Neostigmine
Study Start Date :
Dec 1, 2016
Actual Primary Completion Date :
Apr 22, 2017
Actual Study Completion Date :
Apr 22, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change in TOF ( Train Of Four) measure [for each patient, measure of Train Of Four at 3, 6, 9, 12, 15 minutes]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Michel Baurain Bruxelles Capitale Belgium 1070

Sponsors and Collaborators

  • Université Libre de Bruxelles

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
JOHN NICOLARDOT, MD, Université Libre de Bruxelles
ClinicalTrials.gov Identifier:
NCT03019835
Other Study ID Numbers:
  • B406201629996
  • U1111-1190-7993
First Posted:
Jan 13, 2017
Last Update Posted:
May 19, 2017
Last Verified:
May 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by JOHN NICOLARDOT, MD, Université Libre de Bruxelles
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 19, 2017