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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | neostigmine 0.04 mg.kg associated with atropine 0.02 mg/kg |
|
| 2 | Active Comparator | neostigmine 0.02 mg.kg associated with atropine 0.01 mg/kg |
|
| 3 | Active Comparator | neostigmine 0.1 mg.kg associated with atropine 0.05 mg/kg |
|
| 4 | No Intervention | no injection of neostigmine |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| neostigmine | Drug | 0.04 mg/kg IV bolus, injection when the of train of four is > or = to 40 % |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | from neostigmine injection to TOF ratio = 0.9 and 1.0, evaluated every minute up to 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Florent Capron, doctor | CHD Vendee | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHD Vendée | La Roche-sur-Yon | 85925 | France |
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| ID | Title | Description |
|---|---|---|
| FG000 | Neostigmine 40 µg/kg | neostigmine 0.04 mg.kg associated with atropine 0.02 mg/kg neostigmine: 0.04 mg/kg IV bolus, injection when the of train of four is > or = to 40 % |
| FG001 | Neostigmine 20 µg/kg | neostigmine 0.02 mg.kg associated with atropine 0.01 mg/kg neostigmine: 0.02 mg/kg IV bolus, injection when the of train of four is > or = to 40 % |
| FG002 | Neostigmine 10 µg/kg | neostigmine 0.1 mg.kg associated with atropine 0.05 mg/kg neostigmine: 0.01 mg/kg IV bolus, injection when the of train of four is > or = to 40 % |
| FG003 | Placebo | no injection of neostigmine |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Neostigmine 40 µg/kg | neostigmine 0.04 mg.kg associated with atropine 0.02 mg/kg neostigmine: 0.04 mg/kg IV bolus, injection when the of train of four is > or = to 40 % |
| BG001 | Neostigmine 20 µg/kg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Full Range | minute | from neostigmine injection to TOF ratio = 0.9 and 1.0, evaluated every minute up to 1 hour |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Neostigmine 40 µg/kg | neostigmine 0.04 mg.kg associated with atropine 0.02 mg/kg neostigmine: 0.04 mg/kg IV bolus, injection when the of train of four is > or = to 40 % |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Florent CAPRON | Clinique Jules Verne | 0251171775 | 33 | florent.capron@mla.fr |
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| ID | Term |
|---|---|
| D009388 | Neostigmine |
| ID | Term |
|---|---|
| D050338 | Phenylammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| neostigmine |
| Drug |
0.02 mg/kg IV bolus, injection when the of train of four is > or = to 40 % |
|
| neostigmine | Drug | 0.01 mg/kg IV bolus, injection when the of train of four is > or = to 40 % |
|
neostigmine 0.02 mg.kg associated with atropine 0.01 mg/kg
neostigmine: 0.02 mg/kg IV bolus, injection when the of train of four is > or = to 40 %
| BG002 | Neostigmine 10 µg/kg | neostigmine 0.1 mg.kg associated with atropine 0.05 mg/kg neostigmine: 0.01 mg/kg IV bolus, injection when the of train of four is > or = to 40 % |
| BG003 | Placebo | no injection of neostigmine |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m² |
|
| ASA Physical Status Classification System | ASA I A normal healthy patient ASA II A patient with mild systemic disease ASA III A patient with severe systemic disease ASA IV A patient with severe systemic disease that is a constant threat to life ASA V A moribund patient who is not expected to survive without the operation ASA VI A declared brain-dead patient whose organs are being removed for donor purposes | Count of Participants | Participants |
|
| surgery time | Mean | Standard Deviation | minute |
|
| OG002 | Neostigmine 10 µg/kg | neostigmine 0.1 mg.kg associated with atropine 0.05 mg/kg neostigmine: 0.01 mg/kg IV bolus, injection when the of train of four is > or = to 40 % |
| OG003 | Placebo | no injection of neostigmine |
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Neostigmine 20 µg/kg | neostigmine 0.02 mg.kg associated with atropine 0.01 mg/kg neostigmine: 0.02 mg/kg IV bolus, injection when the of train of four is > or = to 40 % | 0 | 14 | 0 | 14 |
| EG002 | Neostigmine 10 µg/kg | neostigmine 0.1 mg.kg associated with atropine 0.05 mg/kg neostigmine: 0.01 mg/kg IV bolus, injection when the of train of four is > or = to 40 % | 0 | 15 | 0 | 15 |
| EG003 | Placebo | no injection of neostigmine | 0 | 15 | 0 | 15 |
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| D009861 |
| Onium Compounds |