MivacuriumNCT03019835
Can we Antagonize Mivacurium With Neostigmine ?
A study testing Neostigmine (40 mcg / kg) at different time of neuromuscular block's recovery and Spontaneous recovery in people with Mivacurium and Neostigmine, run by Université Libre de Bruxelles at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Mivacurium, Neostigmine, Residual Paralysis
- What is being tested?
- Neostigmine (40 mcg / kg) at different time of neuromuscular block's recovery and Spontaneous recovery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2016to 22 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Bronchial asthma
- Parkinson disease
- BMI> 35
- Known hypersensitivity to neostigmine or to any of the excipients of Neostigmine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 .
Read more
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.
- Conditions
- Mivacurium, Neostigmine, Residual Paralysis
- Being tested
- Neostigmine (40 mcg / kg) at different time of neuromuscular block's recovery, Spontaneous recovery
- Keywords
- mivacurium, neostigmine, antagonism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neostigmine (40 mcg / kg) at different time of neuromuscular block's recoveryDrug
Spontaneous recoveryOther
just measuring the Train Of Four at 3 6 9 12 and 15 minutes and measure the Train Of Four Ratio
| Study group | Role | What they receive |
|---|---|---|
| GROUP 1 | Active comparator | 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) Receives: Drug: Neostigmine (40 mcg / kg) at different time of neuromuscular block's recovery |
| GROUP 2 | Active comparator | 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) Receives: Drug: Neostigmine (40 mcg / kg) at different time of neuromuscular block's recovery |
| GROUP 3 | Active comparator | 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) Receives: Drug: Neostigmine (40 mcg / kg) at different time of neuromuscular block's recovery |
| GROUP 4 | Active comparator | 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) Receives: Drug: Neostigmine (40 mcg / kg) at different time of neuromuscular block's recovery |
| CONTROL | Active comparator | A control group : not receiving an antagonist (spontaneous recovery) Receives: Other: Spontaneous recovery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in TOF ( Train Of Four) measure
Measured: for each patient, measure of Train Of Four at 3, 6, 9, 12, 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study startDec 2016
- Primary completion22 Apr 2017
- Study completion22 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MivacuriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Libre de Bruxelles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JOHN NICOLARDOT, Université Libre de Bruxelles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03019835
- Sponsor's protocol ID
- B406201629996
- Other IDs
- U1111-1190-7993
- Status last verified
- May 2017
- First submitted
- 22 Dec 2016
- Last updated
- 19 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 7880668Baillard 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.
PubMed 16183681Szenohradszky 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.
PubMed 10719950
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can we Antagonize Mivacurium With Neostigmine
- ClinicalTrials.gov ID
- NCT03019835
- Acronym / sponsor ID
- B406201629996
- Conditions
- Mivacurium, Neostigmine, Residual Paralysis
- Keywords
- mivacurium, neostigmine, antagonism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Université Libre de BruxellesUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- 22 Apr 2017 (actual)
- Study completion
- 22 Apr 2017 (actual)
- First posted
- 13 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| GROUP 1 | Active comparator | Drug: Neostigmine (40 mcg / kg) at different time of neuromuscular block's recoveryA 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 comparator | Drug: Neostigmine (40 mcg / kg) at different time of neuromuscular block's recoveryA 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 comparator | Drug: Neostigmine (40 mcg / kg) at different time of neuromuscular block's recoveryA 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 comparator | Drug: Neostigmine (40 mcg / kg) at different time of neuromuscular block's recoveryA 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 comparator | Other: Spontaneous recoveryA control group : not receiving an antagonist (spontaneous recovery) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Bronchial asthma
- Parkinson disease
- BMI> 35
- Known hypersensitivity to neostigmine or to any of the excipients of Neostigmine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neostigmine (40 mcg / kg) at different time of neuromuscular block's recovery | Drug | GROUP 1, GROUP 2, GROUP 3, GROUP 4 |
| Spontaneous recoveryjust measuring the Train Of Four at 3 6 9 12 and 15 minutes and measure the Train Of Four Ratio | Other | CONTROL |
Primary outcome
Change in TOF ( Train Of Four) measure
Time frame: for each patient, measure of Train Of Four at 3, 6, 9, 12, 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2017.
- Results publication: PubMed 7880668Baurain 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 publication: PubMed 16183681Baillard 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 publication: PubMed 10719950Szenohradszky 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.
- Individual participant dataSharing planned: Yes
Related trials for Mivacurium
Not yet recruiting
Antagonism of Neostigmine in Continuous Infusion of Mivacurium
Neuromuscular Blocking Agents
Not yet recruiting
Muscle Relaxant Effect and Safety of Mivacurium Chloride and Succinylcholine for Bronchoscopy
Anesthesia, Bronchoscopy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neostigmine (40 mcg / kg) at different time of neuromuscular block's recovery and Spontaneous recovery in people with Mivacurium and Neostigmine, run by Université Libre de Bruxelles at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in TOF ( Train Of Four) measure (time frame: for each patient, measure of Train Of Four at 3, 6, 9, 12, 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03019835, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2017.