Neuromuscular BlockadeNCT04947306
A Comparison Between TOF Watch® SX and Tetragraph®
An observational study of Neuromuscular Blockade and Neuromuscular Monitoring, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.
Trial summary
This observational study was designed to assess the agreement between the recently marketed electromyographic neuromuscular blockade monitor Tetragraph® (Senzime, Uppsala, Sweden) and the TOF Watch® SX (Organon Teknika B.V., Boxtel, Holland), an accelerometric neuromuscular blockade monitor frequently used in clinical… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neuromuscular Blockade, Neuromuscular Monitoring
- What is being tested?
- Tetragraph® (Senzime, Uppsala, Sweden) and TOF Watch® SX (Organon Teknika B.V., Boxtel, Holland)
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 24 Aug 2020to 30 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients >18 years of age, who are scheduled to undergo any elective procedure under general anesthesia at our Institution in which the administration of rocuronium for neuromuscular blockade is anticipated.
Who may be able to join
- age > 18 years
- Rocuronium bromide use is anticipated for neuromuscular blockade during surgical procedure
- Upper arms will be freely available during the surgical procedure
Who cannot join
- Known neuromuscular disease
- Known allergy to Rocuronium bromide
- end-stage liver disease
- chronic kidney disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Accelerometric Monitoring by TOF Watch® SX and Electromyographic Monitoring by Tetragraph® for Recovery From Neuromuscular Blockade
This observational study was designed to assess the agreement between the recently marketed electromyographic neuromuscular blockade monitor Tetragraph® (Senzime, Uppsala, Sweden) and the TOF Watch® SX (Organon Teknika B.V., Boxtel, Holland), an accelerometric neuromuscular blockade monitor frequently used in clinical practice
Read the detailed description
Before the induction of general anesthesia both monitors will be placed in the same arm. After induction of general anesthesia and before neuromuscular blocking agent administration both devices will be consecutively calibrated and a baseline measurement will be obtained. During the surgical procedure the investigators will monitor neuromuscular function with one of the two devices. Then the investigators will switch the device used as a guide between subsequent patients. The protocol will start as soon as the leading device will register a train-of-four ratio (TOFr) ≥ 0.2. During the protocol a comparison between the two devices will be conducted as soon as the device used as a guide will display a TOFr ≥ 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1. For each of the TOFr reported, we will deliver two subsequent TOF stimulations with the guiding device followed by two TOF stimulations with the other monitor. Both the stimulations delivered by each device and the two consecutive stimulations delivered by different monitors will be conducted 20 sec from one another. Stimulations with the same device will be used to assess intraobserver variability for each methodology, while the second and the third measurements (consecutive stimulations with different devices) will be used to assess agreement between them. The protocol will end when the leading device will show a TOFr ≥ 1.0, or if, at the end of the surgical procedure, acceleromyographic TOFr will be > 0.9.
- Conditions
- Neuromuscular Blockade, Neuromuscular Monitoring
- Being tested
- Tetragraph® (Senzime, Uppsala, Sweden), TOF Watch® SX (Organon Teknika B.V., Boxtel, Holland)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tetragraph® (Senzime, Uppsala, Sweden)Device
Also called Electromyographic neuromuscular monitor
The Tetragraph® is a recently marketed electromyographic neuromuscular monitor that uses a disposable electrode array (TetraSens) that combines stimulating and recording electrodes
TOF Watch® SX (Organon Teknika B.V., Boxtel, Holland)Device
Also called Acceleromyographic neuromuscular monitor
The TOF Watch® SX is a common used neuromuscular monitor
| Study group | Role | What they receive |
|---|---|---|
| All subjects | Adult patients >18 years of age, who are scheduled to undergo any elective procedure under general anesthesia at our Institution in which the administration of rocuronium for neuromuscular blockade is anticipated.
All participants will be monitored with both TOF Watch and Tetragraph neuromuscular monitors. Receives: Device: Tetragraph® (Senzime, Uppsala, Sweden); Device: TOF Watch® SX (Organon Teknika B.V., Boxtel, Holland) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between TOF Watch® SX and Tetragraph® train-of-four ratios
Bias and Limits of Agreement between the two methodologies using Bland-Altman analysis
Measured: Recovery from neuromuscular blockade at the end of the surgical procedure
Secondary outcomes (4)
Agreement between normalized TOF Watch® SX and Tetragraph® train-of-four ratios
Normalized TOF Watch® SX train of four ratios will be calculated as the ratio between actual train-of-four ratio and baseline. Bias and Limits of Agreement will be derived using Bland-Altman analysis
Measured: Recovery from neuromuscular blockade at the end of the surgical procedure
Agreement between TOF Watch® SX and Tetragraph® train-of-four ratios for TOF ratios < 0.8
Normalized TOF Watch® SX train of four ratios will be calculated as the ratio between actual train-of-four ratio and baseline. Bias and Limits of Agreement will be derived using Bland-Altman analysis
Measured: Recovery from neuromuscular blockade at the end of the surgical procedure
Agreement between TOF Watch® SX and Tetragraph® train-of-four ratios for TOF ratios ≥ 0.8
Normalized TOF Watch® SX train of four ratios will be calculated as the ratio between actual train-of-four ratio and baseline. Bias and Limits of Agreement will be derived using Bland-Altman analysis
Measured: Recovery from neuromuscular blockade at the end of the surgical procedure
Absolute and relative intraobserver variability for TOF Watch® SX and Tetragraph®
Absolute intraobserver variability will be calculated as the absolute difference between pairs of consecutive measurements by the same device. Relative intraobserver variability will be calculated as the ratio between the absolute difference and mean of the measurements.
Measured: Recovery from neuromuscular blockade at the end of the surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start24 Aug 2020
- Primary completion30 Oct 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular BlockadeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04947306
- Sponsor's protocol ID
- INT58/20
- Status last verified
- Jun 2021
- First submitted
- 15 Jun 2021
- Last updated
- 1 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Accelerometric Monitoring by TOF Watch® SX and Electromyographic Monitoring by Tetragraph® for Recovery From Neuromuscular Blockade
- ClinicalTrials.gov ID
- NCT04947306
- Acronym / sponsor ID
- INT58/20
- Conditions
- Neuromuscular Blockade, Neuromuscular Monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoUniversity, hospital or other
- Study start
- 24 Aug 2020 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 1 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This observational study was designed to assess the agreement between the recently marketed electromyographic neuromuscular blockade monitor Tetragraph® (Senzime, Uppsala, Sweden) and the TOF Watch® SX (Organon Teknika B.V., Boxtel, Holland), an accelerometric neuromuscular blockade monitor frequently used in clinical practice
Detailed description
Before the induction of general anesthesia both monitors will be placed in the same arm. After induction of general anesthesia and before neuromuscular blocking agent administration both devices will be consecutively calibrated and a baseline measurement will be obtained. During the surgical procedure the investigators will monitor neuromuscular function with one of the two devices. Then the investigators will switch the device used as a guide between subsequent patients. The protocol will start as soon as the leading device will register a train-of-four ratio (TOFr) ≥ 0.2. During the protocol a comparison between the two devices will be conducted as soon as the device used as a guide will display a TOFr ≥ 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1. For each of the TOFr reported, we will deliver two subsequent TOF stimulations with the guiding device followed by two TOF stimulations with the other monitor. Both the stimulations delivered by each device and the two consecutive stimulations delivered by different monitors will be conducted 20 sec from one another. Stimulations with the same device will be used to assess intraobserver variability for each methodology, while the second and the third measurements (consecutive stimulations with different devices) will be used to assess agreement between them. The protocol will end when the leading device will show a TOFr ≥ 1.0, or if, at the end of the surgical procedure, acceleromyographic TOFr will be > 0.9.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects | – | Device: Tetragraph® (Senzime, Uppsala, Sweden), Device: TOF Watch® SX (Organon Teknika B.V., Boxtel, Holland)Adult patients >18 years of age, who are scheduled to undergo any elective procedure under general anesthesia at our Institution in which the administration of rocuronium for neuromuscular blockade is anticipated. All participants will be monitored with both TOF Watch and Tetragraph neuromuscular monitors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients >18 years of age, who are scheduled to undergo any elective procedure under general anesthesia at our Institution in which the administration of rocuronium for neuromuscular blockade is anticipated.
Key inclusion criteria (3 listed)
- age > 18 years
- Rocuronium bromide use is anticipated for neuromuscular blockade during surgical procedure
- Upper arms will be freely available during the surgical procedure
Key exclusion criteria (4 listed)
- Known neuromuscular disease
- Known allergy to Rocuronium bromide
- end-stage liver disease
- chronic kidney 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 |
|---|---|---|
| Tetragraph® (Senzime, Uppsala, Sweden)Also: Electromyographic neuromuscular monitorThe Tetragraph® is a recently marketed electromyographic neuromuscular monitor that uses a disposable electrode array (TetraSens) that combines stimulating and recording electrodes | Device | All subjects |
| TOF Watch® SX (Organon Teknika B.V., Boxtel, Holland)Also: Acceleromyographic neuromuscular monitorThe TOF Watch® SX is a common used neuromuscular monitor | Device | All subjects |
Primary outcome
Agreement between TOF Watch® SX and Tetragraph® train-of-four ratios
Time frame: Recovery from neuromuscular blockade at the end of the surgical procedure
Bias and Limits of Agreement between the two methodologies using Bland-Altman analysis
4 secondary outcomes
Agreement between normalized TOF Watch® SX and Tetragraph® train-of-four ratios
Time frame: Recovery from neuromuscular blockade at the end of the surgical procedure
Agreement between TOF Watch® SX and Tetragraph® train-of-four ratios for TOF ratios < 0.8
Time frame: Recovery from neuromuscular blockade at the end of the surgical procedure
Agreement between TOF Watch® SX and Tetragraph® train-of-four ratios for TOF ratios ≥ 0.8
Time frame: Recovery from neuromuscular blockade at the end of the surgical procedure
Absolute and relative intraobserver variability for TOF Watch® SX and Tetragraph®
Time frame: Recovery from neuromuscular blockade at the end of the surgical procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuromuscular Blockade and Neuromuscular Monitoring, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.
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 3 inclusion and 4 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 1 Jul 2021. 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 Italy. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Agreement between TOF Watch® SX and Tetragraph® train-of-four ratios (time frame: Recovery from neuromuscular blockade at the end of the surgical procedure). 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 1 Jul 2021.