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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001926-25 | EudraCT Number | ||
| B300201316844 | Registry Identifier | Belgisch Registratienummer |
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The effect of neuromuscular blocking agents (NMBA, e.g. rocuronium) on respiratory muscle activity is well known. However, since the availability of sugammadex, to our knowledge, no study has been conducted to evaluate the effect of this novel product on these muscles.
Our hypothesis is that by applying a different strategy in the use of neuromuscular blocking agents and their reversal agents we might see a different activity of the respiratory muscles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single rocuronium dose - placebo | Placebo Comparator | The patients will receive a single rocuronium dose, and no reversal agent. |
|
| Single rocuronium dose - sugammadex | Active Comparator | The patients will receive a single rocuronium dose and sugammadex 2mg/kg as a reversal agent |
|
| Repeated rocuronium dose - neostigmine | Active Comparator | The patients will receive multiple rocuronium doses and neostigmine 70 mcg/kg as a reversal agent |
|
| Repeated rocuronium dose - sugammadex | Active Comparator | The patients will receive multiple rocuronium doses and neostigmine 2mg/kg as a reversal agent |
|
| Continuous rocuronium dose | Active Comparator | The participants will receive a continuous rocuronium infusion and sugammadex 4 mg/kg as a reversal agent |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sugammadex 2mg/kg | Drug |
| ||
| neostigmine |
| Measure | Description | Time Frame |
|---|---|---|
| Electric Activity of the Diaphragm (Microvolts) | From the start of spontaneous breathing till extubation, limited to maximum ten minutes after the onset of spontaneous breathing |
| Measure | Description | Time Frame |
|---|---|---|
| Electric Activity of the Intercostal Muscles | From the start of spontaneous breathing till extubation, limited to maximum ten minutes after the onset of spontaneous breathing |
| Measure | Description | Time Frame |
|---|---|---|
| Centroid Frequency of the EMG, as Trend Variability (Change in %) From First to Last Recording | From the start of spontaneous breathing till extubation, limited to maximum one hour after the onset of spontaneous breathing |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antwerp University Hospital | Edegem | Antwerpen | 2650 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23011532 | Background | Dres M, Schmidt M, Ferre A, Mayaux J, Similowski T, Demoule A. Diaphragm electromyographic activity as a predictor of weaning failure. Intensive Care Med. 2012 Dec;38(12):2017-25. doi: 10.1007/s00134-012-2700-3. Epub 2012 Sep 26. | |
| 31629404 | Derived | Schepens T, Janssens K, Maes S, Wildemeersch D, Vellinga J, Jorens PG, Saldien V. Respiratory muscle activity after spontaneous, neostigmine- or sugammadex-enhanced recovery of neuromuscular blockade: a double blind prospective randomized controlled trial. BMC Anesthesiol. 2019 Oct 19;19(1):187. doi: 10.1186/s12871-019-0863-y. |
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Patients were screened for inclusion and approached the night prior to their elective surgery
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Rocuronium Dose - Placebo | The patients will receive a single rocuronium dose, and no reversal agent. placebo Single rocuronium dose |
| FG001 | Single Rocuronium Dose - Sugammadex |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
|
| sugammadex 4mg/kg | Drug |
|
| placebo | Drug |
|
| Single rocuronium dose | Drug |
|
| Repeated rocuronium dose | Drug |
|
| Continuous rocuronium infusion | Drug |
|
The patients will receive a single rocuronium dose and sugammadex 2mg/kg as a reversal agent
sugammadex 2mg/kg
Single rocuronium dose
| FG002 | Repeated Rocuronium Dose - Neostigmine | The patients will receive multiple rocuronium doses and neostigmine 50 mcg/kg as a reversal agent neostigmine Repeated rocuronium dose |
| FG003 | Repeated Rocuronium Dose - Sugammadex | The patients will receive multiple rocuronium doses and neostigmine 2mg/kg as a reversal agent sugammadex 2mg/kg Repeated rocuronium dose |
| FG004 | Continuous Rocuronium Dose | The participants will receive a continuous rocuronium infusion and sugammadex 4 mg/kg as a reversal agent sugammadex 4mg/kg Continuous rocuronium infusion |
| Received Intervention |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Rocuronium Dose - Placebo | The patients will receive a single rocuronium dose, and no reversal agent. placebo Single rocuronium dose |
| BG001 | Single Rocuronium Dose - Sugammadex | The patients will receive a single rocuronium dose and sugammadex 2mg/kg as a reversal agent sugammadex 2mg/kg Single rocuronium dose |
| BG002 | Repeated Rocuronium Dose - Neostigmine | The patients will receive multiple rocuronium doses and neostigmine 50 mcg/kg as a reversal agent neostigmine Repeated rocuronium dose |
| BG003 | Repeated Rocuronium Dose - Sugammadex | The patients will receive multiple rocuronium doses and neostigmine 2mg/kg as a reversal agent sugammadex 2mg/kg Repeated rocuronium dose |
| BG004 | Continuous Rocuronium Dose | The participants will receive a continuous rocuronium infusion and sugammadex 4 mg/kg as a reversal agent sugammadex 4mg/kg Continuous rocuronium infusion |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Body Mass Index | Median | Inter-Quartile Range | kg/m2 |
|
| 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 | Electric Activity of the Diaphragm (Microvolts) | Posted | Median | Inter-Quartile Range | microvolt | From the start of spontaneous breathing till extubation, limited to maximum ten minutes after the onset of spontaneous breathing |
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| Secondary | Electric Activity of the Intercostal Muscles | Posted | Median | Inter-Quartile Range | microvolt | From the start of spontaneous breathing till extubation, limited to maximum ten minutes after the onset of spontaneous breathing |
| |||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Centroid Frequency of the EMG, as Trend Variability (Change in %) From First to Last Recording | Not Posted | From the start of spontaneous breathing till extubation, limited to maximum one hour after the onset of spontaneous breathing | Participants |
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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 | Single Rocuronium Dose - Placebo | The patients will receive a single rocuronium dose, and no reversal agent. placebo Single rocuronium dose | 0 | 15 | 0 | 15 | ||
| EG001 | Single Rocuronium Dose - Sugammadex | The patients will receive a single rocuronium dose and sugammadex 2mg/kg as a reversal agent sugammadex 2mg/kg Single rocuronium dose | 0 | 15 | 0 | 15 | ||
| EG002 | Repeated Rocuronium Dose - Neostigmine | The patients will receive multiple rocuronium doses and neostigmine 50 mcg/kg as a reversal agent neostigmine Repeated rocuronium dose | 0 | 15 | 0 | 15 | ||
| EG003 | Repeated Rocuronium Dose - Sugammadex | The patients will receive multiple rocuronium doses and neostigmine 2mg/kg as a reversal agent sugammadex 2mg/kg Repeated rocuronium dose | 0 | 15 | 0 | 15 | ||
| EG004 | Continuous Rocuronium Dose | The participants will receive a continuous rocuronium infusion and sugammadex 4 mg/kg as a reversal agent sugammadex 4mg/kg Continuous rocuronium infusion | 0 | 15 | 0 | 15 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Tom Schepens | Antwerp University Hospital | 003238213265 | tom.schepens@uza.be |
| ID | Term |
|---|---|
| D018908 | Muscle Weakness |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077122 | Sugammadex |
| D009388 | Neostigmine |
| ID | Term |
|---|---|
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D003912 | Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D050338 | Phenylammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |
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| Male |
|
| Continuous Rocuronium Dose |
The participants will receive a continuous rocuronium infusion and sugammadex 4 mg/kg as a reversal agent sugammadex 4mg/kg Continuous rocuronium infusion |
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