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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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Aim: To explore
We will collect data from 7 Danish anaesthesia departments, using data from the Anaesthesia Information Management System (AIMS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eligible patients | Patients ≥15 years of age who received general anaesthesia with neuromuscular blockade in the last 18 months up until the time of data collection. Patients, who are eligible more than once, i.e. undergoing general anaesthesia on more than one occasion, will be included in the analyses as a case for every general anaesthetic received. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rocuronium | Drug |
| ||
| Succinylcholine |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With and Without Objective Neuromuscular Monitoring (Acceleromyography) in Cases Receiving a Non-depolarizing Neuromuscular Blocking Agent (NMBA) (Yes/no) | in the period from induction of anaesthesia to termination of anaesthesia, usually 2 hours | |
| Number of Participants With and Without Objective Neuromuscular Monitoring (Acceleromyography) in Cases Receiving a Depolarizing NMBA (Succinylcholine) (Yes/no) | in the period from induction of anaesthesia to termination of anaesthesia, usually 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Last Recorded Train-of-four (TOF) Ratio Before Tracheal Extubation or Removal of Supraglottic Airway Device in Patients Receiving a Non-depolarizing NMBA | The train-of-four (TOF) ratio is the ratio between the last and first measurements after four stimuli of the ulnar nerve at 2 Hz. The ratio should be at least 0.9 before tracheal extubation. | in the period from induction of anaesthesia to termination of anaesthesia, usually 2 hours |
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Inclusion Criteria:
Patients who received general anaesthesia with neuromuscular blockade in one of the 7 hospitals providing data for the study in the last 18 months up until the time of data collection
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Patients who received general anaesthesia with neuromuscular blockade
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| Name | Affiliation | Role |
|---|---|---|
| Jakob L Thomsen, MD | Sponsor principal investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herlev Hospital | Herlev | Denmark |
Sharing of data not included in the permissions granted by authorities stated below
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Estimated number of included cases
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| ID | Title | Description |
|---|---|---|
| FG000 | Eligible Patients | Patients ≥15 years of age who received general anaesthesia with neuromuscular blockade in the last 18 months up until the time of data collection. Patients, who are eligible more than once, i.e. undergoing general anaesthesia on more than one occasion, will be included in the analyses as a case for every general anaesthetic received. Rocuronium Succinylcholine Cisatracurium Mivacurium Objective neuromuscular monitoring (acceleromyography) Sugammadex Neostigmine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 3, 2019 | Aug 3, 2019 |
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| Cisatracurium | Drug |
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| Mivacurium | Drug |
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| Objective neuromuscular monitoring (acceleromyography) | Device |
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| Sugammadex | Drug |
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| Neostigmine | Drug |
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| Number of Participants With and Without Administration of Sugammadex in Cases Receiving a Non-depolarizing NMBA (Yes/no) | in the period from induction of anaesthesia to discharge from the post-anaesthesia care unit, usually 5 hours |
| Number of Participants With and Without Administration of Neostigmine in Cases Receiving a Non-depolarizing NMBA (Yes/no) | in the period from induction of anaesthesia to discharge from the post-anaesthesia care unit, usually 5 hours |
| Time in Minutes From Tracheal Extubation or Removal of Supraglottic Airway Device to Discharge From Post-anaesthesia Care Unit in Cases Involving a Non-depolarizing NMBA With and Without Neuromuscular Monitoring, Respectively | in the period from induction of anaesthesia to discharge from the post-anaesthesia care unit, usually 180 minutes |
| Number of Participants With and Without Mild Oxygen Desaturation (<90%, But >80%) in Cases Receiving a Non-depolarizing NMBA | in the period between tracheal extubation or removal of supraglottic airway device and discharge from post-anaesthesia care unit, assessed up to 24 hours |
| Number of Participants With and Without Severe Oxygen Desaturation (<80%) in Cases Receiving a Non-depolarizing NMBA | in the period between tracheal extubation or removal of supraglottic airway device and discharge from post-anaesthesia care unit, assessed up to 24 hours |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Eligible Patients | Patients ≥15 years of age who received general anaesthesia with neuromuscular blockade in the last 18 months up until the time of data collection. Patients, who are eligible more than once, i.e. undergoing general anaesthesia on more than one occasion, will be included in the analyses as a case for every general anaesthetic received. Rocuronium Succinylcholine Cisatracurium Mivacurium Objective neuromuscular monitoring (acceleromyography) Sugammadex Neostigmine |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| 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 | Number of Participants With and Without Objective Neuromuscular Monitoring (Acceleromyography) in Cases Receiving a Non-depolarizing Neuromuscular Blocking Agent (NMBA) (Yes/no) | Patients receiving non-depolarizing neuromuscular blocking agent | Posted | Count of Participants | Participants | in the period from induction of anaesthesia to termination of anaesthesia, usually 2 hours |
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| Primary | Number of Participants With and Without Objective Neuromuscular Monitoring (Acceleromyography) in Cases Receiving a Depolarizing NMBA (Succinylcholine) (Yes/no) | Patients receiving succinylcholine only | Posted | Count of Participants | Participants | in the period from induction of anaesthesia to termination of anaesthesia, usually 2 hours |
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| Secondary | Last Recorded Train-of-four (TOF) Ratio Before Tracheal Extubation or Removal of Supraglottic Airway Device in Patients Receiving a Non-depolarizing NMBA | The train-of-four (TOF) ratio is the ratio between the last and first measurements after four stimuli of the ulnar nerve at 2 Hz. The ratio should be at least 0.9 before tracheal extubation. | Only participants with data on the outcome was analyzed, as per protocol. | Posted | Median | Inter-Quartile Range | Train-of-four ratio | in the period from induction of anaesthesia to termination of anaesthesia, usually 2 hours |
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| Secondary | Number of Participants With and Without Administration of Sugammadex in Cases Receiving a Non-depolarizing NMBA (Yes/no) | Only participants with data on the outcome was analyzed, as per protocol. | Posted | Count of Participants | Participants | in the period from induction of anaesthesia to discharge from the post-anaesthesia care unit, usually 5 hours |
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| Secondary | Number of Participants With and Without Administration of Neostigmine in Cases Receiving a Non-depolarizing NMBA (Yes/no) | Only participants with data on the outcome was analyzed, as per protocol. | Posted | Count of Participants | Participants | in the period from induction of anaesthesia to discharge from the post-anaesthesia care unit, usually 5 hours |
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| Secondary | Time in Minutes From Tracheal Extubation or Removal of Supraglottic Airway Device to Discharge From Post-anaesthesia Care Unit in Cases Involving a Non-depolarizing NMBA With and Without Neuromuscular Monitoring, Respectively | Only participants with data on the outcome was analyzed, as per protocol. | Posted | Median | Inter-Quartile Range | Minutes | in the period from induction of anaesthesia to discharge from the post-anaesthesia care unit, usually 180 minutes |
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| Secondary | Number of Participants With and Without Mild Oxygen Desaturation (<90%, But >80%) in Cases Receiving a Non-depolarizing NMBA | Only participants with data on the outcome was analyzed, as per protocol. | Posted | Count of Participants | Participants | in the period between tracheal extubation or removal of supraglottic airway device and discharge from post-anaesthesia care unit, assessed up to 24 hours |
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| Secondary | Number of Participants With and Without Severe Oxygen Desaturation (<80%) in Cases Receiving a Non-depolarizing NMBA | Only participants with data on the outcome was analyzed, as per protocol. | Posted | Count of Participants | Participants | in the period between tracheal extubation or removal of supraglottic airway device and discharge from post-anaesthesia care unit, assessed up to 24 hours |
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Averse events data were not collected for the study because it was a retrospective database study. Adverse events were collected and reported by individual institutions according to local procedure.
Averse events data were not collected for the study because it was a retrospective database study. Adverse events were collected and reported by individual institutions according to local procedure.
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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 | Eligible Patients | Patients ≥15 years of age who received general anaesthesia with neuromuscular blockade in the last 18 months up until the time of data collection. Patients, who are eligible more than once, i.e. undergoing general anaesthesia on more than one occasion, will be included in the analyses as a case for every general anaesthetic received. Rocuronium Succinylcholine Cisatracurium Mivacurium Objective neuromuscular monitoring (acceleromyography) Sugammadex Neostigmine | 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. JLD Thomsen | Herlev Hospital, research unit, anesthesia | 004538633863 | prs@demants.dk |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 3, 2019 | Aug 3, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000077123 | Rocuronium |
| D013390 | Succinylcholine |
| C101584 | cisatracurium |
| D000077590 | Mivacurium |
| D000077122 | Sugammadex |
| D009388 | Neostigmine |
| ID | Term |
|---|---|
| D000732 | Androstanols |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D002794 | Choline |
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D013386 | Succinates |
| D003998 | Dicarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009861 | Onium Compounds |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D003912 | Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D050338 | Phenylammonium Compounds |
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