AnesthesiaPhase 3NEODECNCT00847938
Comparision of Different Dose of Neostigmine at Advanced Decurarization
A Phase 3 study testing neostigmine in people with Anesthesia, run by Centre Hospitalier Departemental Vendee at 1 site in France.
Trial summary
Neuromuscular blockers (NMB) are currently used in anesthesia. Residual paralysis (RP) due to NMB is responsible for respiratory disorders after extubation. Neuromuscular blockade is monitored by train-of-four (TOF) stimulation at the adductor pollicis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- neostigmine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2009to Nov 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- patient > 18 years
- informed consent signed
- Patient undergoing any type of scheduled surgery under general anesthesia for which curarization with eventually a maintenance is indicated
- ASA score between I to III
Who cannot join
- patient > 75 years and < 18 years
- body mass index > 32 mg/m²
- neurology disease, neuromuscular or muscular disease
- peripheral neuropathy
- coronary heart disease
- asthma
Show all 16Show fewer
- familial history of malign hyperthermia
- difficulty of intubation and ventilation
- full stomach
- known or suspected allergy to one of the study drug
- mecanique obstruction of digestive or urinary tract
- open-angle glaucoma
- patient with risk of urinary retention linked to urethra-prostatic disorder
- concomittant medication with a influence known on neuromuscular (aminosid, anti-convulsif and corticosteroid
- child bearing women or nursing mother
- no affiliation at a social security
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Controlled, Double-blind, Prospective Study, Comparing Different Doses of Neostigmine at Advanced Decurarization .
Neuromuscular blockers (NMB) are currently used in anesthesia. Residual paralysis (RP) due to NMB is responsible for respiratory disorders after extubation. Neuromuscular blockade is monitored by train-of-four (TOF) stimulation at the adductor pollicis. To exclude a RP a mechanomyographic TOF ratio of 0.9 is mandatory. But mecanomyography is not available in clinical routine. Acceleromyography is the most currently monitoring available in daily practice but it has been proved that an acceloromyographic (AMG) TOF ratio of 1.0 is necessary to exclude a RP. The incidence of RP in recovery room is underestimated. So to perform a safe extubation, reversal of the neuromuscular blockade is necessary when an AMG TOF ratio has not reached 1.0. Reversal of neuromuscular blockade is achieved with neostigmine. The recommended dose is 0.04 mg/kg. The administration of neostigmine causes parasympathomimetic effects which has to be reversed with atropine. When neuromuscular blockade is light (AMG TOF ratio of 0.4 which corresponds to the absence of fade at the visual evaluation of the TOF), a low dose of neostigmine might be sufficient with less side effects expected. The goal of the study is to compare the delay between a light neuromuscular block and an AMG TOF ratio of 1.0 for three neostigmine regimens of neostigmine 0.04, 0.02, 0.01 mg/kg with atropine respectively 0.02, 0.01, 0.005 mg/kg and a placebo.
- Conditions
- Anesthesia
- Being tested
- neostigmine
- Keywords
- neostigmine, neuromuscular blocking agent, train of four, anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neostigmineDrug
0.04 mg/kg IV bolus, injection when the of train of four is > or = to 40 %
neostigmineDrug
0.02 mg/kg IV bolus, injection when the of train of four is > or = to 40 %
neostigmineDrug
0.01 mg/kg IV bolus, injection when the of train of four is > or = to 40 %
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | neostigmine 0.04 mg.kg associated with atropine 0.02 mg/kg Receives: Drug: neostigmine |
| 2 | Active comparator | neostigmine 0.02 mg.kg associated with atropine 0.01 mg/kg Receives: Drug: neostigmine |
| 3 | Active comparator | neostigmine 0.1 mg.kg associated with atropine 0.05 mg/kg Receives: Drug: neostigmine |
| 4 | No intervention | no injection of neostigmine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mesure of the Train-of-four (TOF)
train-of-four monitoring (also known as neuromuscular monitoring), is a technique used during recovery from the application of general anesthesia to objectively determine how well a patient's muscles are able to function, by recording muscle response after nerves electrical stimulation.
Measured: from neostigmine injection to TOF ratio = 0.9 and 1.0, evaluated every minute up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2009 (estimated)
- Study startMar 2009
- Primary completionOct 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnesthesiaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florent Capron, doctor, Principal investigator, CHD Vendee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00847938
- Sponsor's protocol ID
- CHD066-08
- Acronym
- NEODEC
- Status last verified
- May 2019
- First submitted
- 18 Feb 2009
- Last updated
- 29 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled, Double-blind, Prospective Study, Comparing Different Doses of Neostigmine at Advanced Decurarization .
- ClinicalTrials.gov ID
- NCT00847938
- Acronym / sponsor ID
- NEODEC / CHD066-08
- Conditions
- Anesthesia
- Keywords
- neostigmine, neuromuscular blocking agent, train of four, anesthesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 19 Feb 2009 (estimated)
- Results
- Posted 17 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Neuromuscular blockers (NMB) are currently used in anesthesia. Residual paralysis (RP) due to NMB is responsible for respiratory disorders after extubation. Neuromuscular blockade is monitored by train-of-four (TOF) stimulation at the adductor pollicis. To exclude a RP a mechanomyographic TOF ratio of 0.9 is mandatory. But mecanomyography is not available in clinical routine. Acceleromyography is the most currently monitoring available in daily practice but it has been proved that an acceloromyographic (AMG) TOF ratio of 1.0 is necessary to exclude a RP. The incidence of RP in recovery room is underestimated. So to perform a safe extubation, reversal of the neuromuscular blockade is necessary when an AMG TOF ratio has not reached 1.0. Reversal of neuromuscular blockade is achieved with neostigmine. The recommended dose is 0.04 mg/kg. The administration of neostigmine causes parasympathomimetic effects which has to be reversed with atropine. When neuromuscular blockade is light (AMG TOF ratio of 0.4 which corresponds to the absence of fade at the visual evaluation of the TOF), a low dose of neostigmine might be sufficient with less side effects expected. The goal of the study is to compare the delay between a light neuromuscular block and an AMG TOF ratio of 1.0 for three neostigmine regimens of neostigmine 0.04, 0.02, 0.01 mg/kg with atropine respectively 0.02, 0.01, 0.005 mg/kg and a placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: neostigmineneostigmine 0.04 mg.kg associated with atropine 0.02 mg/kg |
| 2 | Active comparator | Drug: neostigmineneostigmine 0.02 mg.kg associated with atropine 0.01 mg/kg |
| 3 | Active comparator | Drug: neostigmineneostigmine 0.1 mg.kg associated with atropine 0.05 mg/kg |
| 4 | No intervention | –no injection of neostigmine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patient > 18 years
- informed consent signed
- Patient undergoing any type of scheduled surgery under general anesthesia for which curarization with eventually a maintenance is indicated
- ASA score between I to III
Key exclusion criteria (16 listed)
- patient > 75 years and < 18 years
- body mass index > 32 mg/m²
- neurology disease, neuromuscular or muscular disease
- peripheral neuropathy
- coronary heart disease
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 |
|---|---|---|
| neostigmine0.04 mg/kg IV bolus, injection when the of train of four is > or = to 40 % | Drug | 1 |
| neostigmine0.02 mg/kg IV bolus, injection when the of train of four is > or = to 40 % | Drug | 2 |
| neostigmine0.01 mg/kg IV bolus, injection when the of train of four is > or = to 40 % | Drug | 3 |
Primary outcome
Mesure of the Train-of-four (TOF)
Time frame: from neostigmine injection to TOF ratio = 0.9 and 1.0, evaluated every minute up to 1 hour
train-of-four monitoring (also known as neuromuscular monitoring), is a technique used during recovery from the application of general anesthesia to objectively determine how well a patient's muscles are able to function, by recording muscle response after nerves electrical stimulation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Florent Capron, doctor principal investigator
CHD Vendee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing neostigmine in people with Anesthesia, run by Centre Hospitalier Departemental Vendee at 1 site in France.
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 4 inclusion and 16 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 29 May 2019. 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 France. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mesure of the Train-of-four (TOF) (time frame: from neostigmine injection to TOF ratio = 0.9 and 1.0, evaluated every minute up to 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 May 2019.