Neuromuscular Blockade
Conditions
Keywords
Residual nerve blockade, Neuromuscular monitoring, Residual curarization, Neuromuscular blocking agents, E-learning, Web based learning
Brief summary
To assess the impact of an e-learning course in neuromuscular monitoring on the frequency of application of objective neuromuscular monitoring for assessment of depth of neuromuscular blockade in general anaesthesia and secondarily on the incidence of residual neuromuscular blockade after anesthesia. We will collect data prospectively from 6 Danish anaesthesia departments from the time of intervention, using data from the Anaesthesia Information Management System (AIMS). Baseline data is obtained from another study based on the same data extraction procedure (NCT02914119).
Interventions
OTHERE-learning course in neuromuscular monitoring
An e-learning course designed to assess the challenges and common problems experienced by anesthetists when monitoring the neuromuscular blockade during general anesthesia.
Sponsors
Merck Sharp & Dohme LLC
Herlev Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Inclusion Departments We will include the 6 largest anaesthesia departments in the Zealand Region of Denmark. Anaesthetists We will include the following anaesthesia personnel as anaesthetists: nurse anaesthetists in training, nurse anaesthetists, first year residents in anaesthesiology, residents in the last 4 years of training in anaesthesiology, and specialist consultants in anaesthesia. Patients We will include and collect data from all patients undergoing general anaesthesia with neuromuscular blockade in each data collection period. Patients, who are eligible more than once, i.e. undergoing general anaesthesia on more than one occasion, will be included in the analyses with a case for every general anaesthetic received.
Exclusion criteria
We will exclude personnel without clinical functions, i.e. administrative personnel.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Application of Objective Neuromuscular Monitoring (Acceleromyography) in Cases Receiving a Depolarizing Neuromuscular Blocking Agent (NMBA) (Succinylcholine) (Yes/no) | in the period from induction of anaesthesia to termination of anaesthesia, usually 2 hours | Number of Participants Who Received a Depolarizing Neuromuscular Blocking Agent (NMBA) (Succinylcholine) and was Monitored with Objective Neuromuscular Monitoring (Acceleromyography). Data on neuromuscular monitoring is automatically registered in the electronic patient chart when the equipment for acceleromyography is activated. |
| Application of Objective Neuromuscular Monitoring (Acceleromyography) in Cases Receiving a Non-depolarizing NMBA (Yes/no) | in the period from induction of anaesthesia to termination of anaesthesia, usually 2 hours | Number of Participants Who Received a Non-depolarizing Neuromuscular Blocking Agent (NMBA) and was Monitored with Objective Neuromuscular Monitoring (Acceleromyography). Data on neuromuscular monitoring is automatically registered in the electronic patient chart when the equipment for acceleromyography is activated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Last Recorded Train-of-four (TOF) Ratio Before Tracheal Extubation or Removal of Supraglottic Airway Device in Patients Receiving a Non-depolarizing NMBA | in the period from induction of anaesthesia to termination of anaesthesia, usually 2 hours] | The Train-of-four (TOF) ratio is the ratio of the fourth to the first muscle response after 4 stimuli at the ulnar nerve at the wrist at 2 Hz. The response is measured using acceleromyography. If the last measurement is performed before return of any muscle function, the ration can not be given. |
| Administration of More Than One Reversal Agent 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 | If the total dose of neostigmine is bigger than (\>) the first dose administered, the outcome is yes. |
| 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 | If the total dose of neostigmine in the anaesthesia information management system is \> 0, the outcome is yes. |
| 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 | If the total dose of sugammadex in the anaesthesia information management system is \> 0, the outcome is yes. |
| 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 | in the period from induction of anaesthesia to discharge from the post-anaesthesia care unit, usually 180 minutes | — |
Countries
Denmark
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| E-learning Course E-learning course in neuromuscular monitoring: An e-learning course designed to assess the challenges and common problems experienced by anesthetists when monitoring the neuromuscular blockade during general anesthesia. | 6,525 |
| Total | 6,525 |
Baseline characteristics
| Characteristic | E-learning Course | — |
|---|---|---|
| Age, Continuous | 57.8 years STANDARD_DEVIATION 19.3 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Denmark | 6525 participants | — |
| Sex: Female, Male Female | 3597 Participants | — |
| Sex: Female, Male Male | 2928 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6,525 |
| other Total, other adverse events | 0 / 6,525 |
| serious Total, serious adverse events | 0 / 6,525 |
Outcome results
Primary
Application of Objective Neuromuscular Monitoring (Acceleromyography) in Cases Receiving a Depolarizing Neuromuscular Blocking Agent (NMBA) (Succinylcholine) (Yes/no)
Number of Participants Who Received a Depolarizing Neuromuscular Blocking Agent (NMBA) (Succinylcholine) and was Monitored with Objective Neuromuscular Monitoring (Acceleromyography). Data on neuromuscular monitoring is automatically registered in the electronic patient chart when the equipment for acceleromyography is activated.
Time frame: in the period from induction of anaesthesia to termination of anaesthesia, usually 2 hours
Population: Only patients who received a Depolarizing Neuromuscular Blocking Agent (NMBA) (Succinylcholine) are analyzed in this outcome.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| E-learning Course | Application of Objective Neuromuscular Monitoring (Acceleromyography) in Cases Receiving a Depolarizing Neuromuscular Blocking Agent (NMBA) (Succinylcholine) (Yes/no) | 1425 Participants |
Primary
Application of Objective Neuromuscular Monitoring (Acceleromyography) in Cases Receiving a Non-depolarizing NMBA (Yes/no)
Number of Participants Who Received a Non-depolarizing Neuromuscular Blocking Agent (NMBA) and was Monitored with Objective Neuromuscular Monitoring (Acceleromyography). Data on neuromuscular monitoring is automatically registered in the electronic patient chart when the equipment for acceleromyography is activated.
Time frame: in the period from induction of anaesthesia to termination of anaesthesia, usually 2 hours
Population: Only patients receiving a non-depolarizing neuromuscular blocking agent are analyzed in this outcome
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| E-learning Course | Application of Objective Neuromuscular Monitoring (Acceleromyography) in Cases Receiving a Non-depolarizing NMBA (Yes/no) | 3172 Participants |
Secondary
Administration of More Than One Reversal Agent in Cases Receiving a Non-depolarizing NMBA (Yes/no)
If the total dose of neostigmine is bigger than (\>) the first dose administered, the outcome is yes.
Time frame: in the period from induction of anaesthesia to discharge from the post-anaesthesia care unit, usually 5 hours
Population: Only patients receiving a non-depolarizing neuromuscular blocking agent are analyzed in this outcome.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| E-learning Course | Administration of More Than One Reversal Agent in Cases Receiving a Non-depolarizing NMBA (Yes/no) | 213 Participants |
Secondary
Administration of Neostigmine in Cases Receiving a Non-depolarizing NMBA (Yes/no)
If the total dose of neostigmine in the anaesthesia information management system is \> 0, the outcome is yes.
Time frame: in the period from induction of anaesthesia to discharge from the post-anaesthesia care unit, usually 5 hours
Population: Only patients receiving a non-depolarizing neuromuscular blocking agent are analyzed in this outcome.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| E-learning Course | Administration of Neostigmine in Cases Receiving a Non-depolarizing NMBA (Yes/no) | 2047 Participants |
Secondary
Administration of Sugammadex in Cases Receiving a Non-depolarizing NMBA (Yes/no)
If the total dose of sugammadex in the anaesthesia information management system is \> 0, the outcome is yes.
Time frame: in the period from induction of anaesthesia to discharge from the post-anaesthesia care unit, usually 5 hours
Population: Only patients receiving a non-depolarizing neuromuscular blocking agent are analyzed in this outcome.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| E-learning Course | Administration of Sugammadex in Cases Receiving a Non-depolarizing NMBA (Yes/no) | 85 Participants |
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 of the fourth to the first muscle response after 4 stimuli at the ulnar nerve at the wrist at 2 Hz. The response is measured using acceleromyography. If the last measurement is performed before return of any muscle function, the ration can not be given.
Time frame: in the period from induction of anaesthesia to termination of anaesthesia, usually 2 hours]
Population: Only patients receiving a non-depolarizing neuromuscular blocking agent, monitored with acceleromyography and with a valid TOF ratio in the last three measurements are included in this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| E-learning Course | Last Recorded Train-of-four (TOF) Ratio Before Tracheal Extubation or Removal of Supraglottic Airway Device in Patients Receiving a Non-depolarizing NMBA | 95.23 ratio | Standard Deviation 29.57 |
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
Time frame: in the period from induction of anaesthesia to discharge from the post-anaesthesia care unit, usually 180 minutes
Population: Only patients receiving a non-depolarizing neuromuscular blocking agent with data on length-of-stay in the post-anaesthesia care unit are analyzed in this outcome.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| E-learning Course | 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 | 100 minutes |