Neuromuscular BlockadeNCT00472121
The Precision and Arm-to-Arm Variation of Mechanomyography and Acceleromyography for Monitoring of Neuromuscular Block
An observational study of Neuromuscular Blockade, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The purpose of the study is the examine the precision of acceleromyography and mechanomyography during recovery from a neuromuscular blocking agent and to examine whether there is any difference in monitoring block at the dominant or non-dominant arm. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neuromuscular Blockade
- What is being tested?
- TOF-Watch SX (neuromuscular monitor)
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 1 siteDenmark
- Study dates
- May 2007to Oct 2007
- 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 to 65 years
- All sexes
- Adult, Older adult
Who may be able to join
- ASA I-III
- General anesthesia >1 hour
- Surgery in supine position w. possibility of monitoring the neuromuscular block at both arms (n. ulnaris stimulation/thumb response)
- Written informed content
Who cannot join
- Neuromuscular disorders, hepatic and renal dysfunction
- Medication expected to interfere with the neuromuscular blocking agent
- Allergy to any medication used during anaesthesia
- Body weight less or exceeding 20% of ideal body weight
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Precision and Arm-to-Arm Variation og Mechanomyography and Acceleromyography for Monitoring the Neuromuscular Block During Anesthesia, A Randomized Controlled Study
The purpose of the study is the examine the precision of acceleromyography and mechanomyography during recovery from a neuromuscular blocking agent and to examine whether there is any difference in monitoring block at the dominant or non-dominant arm. Our hypothesis is that there is no significant difference in neither the precision nor the level of block in the contralateral arms.
- Conditions
- Neuromuscular Blockade
- Being tested
- TOF-Watch SX (neuromuscular monitor)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOF-Watch SX (neuromuscular monitor)Device
The variation between arms (dominant or non-dominant) when monitored with the same method on both arms
| Study group | Role | What they receive |
|---|---|---|
| 1: AMG | Not described Receives: Device: TOF-Watch SX (neuromuscular monitor) | |
| 2: MMG | Not described Receives: Device: TOF-Watch SX (neuromuscular monitor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Precision at the contralateral arms using the average residual coefficient of variation over subsequent linear regressions (detrending) over time
Secondary outcomes (6)
Bias and limits of agreement between control TOF, reappearance of T1, T2, T3, T4
T1 height at reappearance of T1-T4
Time to T1=25%
Interval 25-75%
Time to TOF 0.9 and 1.0 with and without normalization
Time to stable T1 and stable TOF
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2007 (estimated)
- Study startMay 2007
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular BlockadeStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Investigators
- Casper C Kjær, MD, Principal investigator, Dep. of anaesthesia 4231, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00472121
- Sponsor's protocol ID
- MMG-MMG
- Status last verified
- Apr 2008
- First submitted
- 10 May 2007
- Last updated
- 18 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Claudius C, Skovgaard LT, Viby-Mogensen J. Arm-to-arm variation when evaluating neuromuscular block: an analysis of the precision and the bias and agreement between arms when using mechanomyography or acceleromyography. Br J Anaesth. 2010 Sep;105(3):310-7. doi: 10.1093/bja/aeq162. Epub 2010 Jun 30.
PubMed 20595196
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Precision and Arm-to-Arm Variation og Mechanomyography and Acceleromyography for Monitoring the Neuromuscular Block During Anesthesia, A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT00472121
- Acronym / sponsor ID
- MMG-MMG
- Conditions
- Neuromuscular Blockade
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 11 May 2007 (estimated)
- 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.
The purpose of the study is the examine the precision of acceleromyography and mechanomyography during recovery from a neuromuscular blocking agent and to examine whether there is any difference in monitoring block at the dominant or non-dominant arm. Our hypothesis is that there is no significant difference in neither the precision nor the level of block in the contralateral arms.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: AMG | – | Device: TOF-Watch SX (neuromuscular monitor) |
| 2: MMG | – | Device: TOF-Watch SX (neuromuscular monitor) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA I-III
- General anesthesia >1 hour
- Surgery in supine position w. possibility of monitoring the neuromuscular block at both arms (n. ulnaris stimulation/thumb response)
- Written informed content
Key exclusion criteria (5 listed)
- Neuromuscular disorders, hepatic and renal dysfunction
- Medication expected to interfere with the neuromuscular blocking agent
- Allergy to any medication used during anaesthesia
- Body weight less or exceeding 20% of ideal body weight
- Pregnancy or breastfeeding
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 |
|---|---|---|
| TOF-Watch SX (neuromuscular monitor)The variation between arms (dominant or non-dominant) when monitored with the same method on both arms | Device | 1: AMG, 2: MMG |
Primary outcome
Precision at the contralateral arms using the average residual coefficient of variation over subsequent linear regressions (detrending) over time
6 secondary outcomes
Bias and limits of agreement between control TOF, reappearance of T1, T2, T3, T4
T1 height at reappearance of T1-T4
Time to T1=25%
Interval 25-75%
Time to TOF 0.9 and 1.0 with and without normalization
Time to stable T1 and stable TOF
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 18 Apr 2008.
- Derived from this study: PubMed 20595196Claudius C, Skovgaard LT, Viby-Mogensen J. Arm-to-arm variation when evaluating neuromuscular block: an analysis of the precision and the bias and agreement between arms when using mechanomyography or acceleromyography. Br J Anaesth. 2010 Sep;105(3):310-7. doi: 10.1093/bja/aeq162. Epub 2010 Jun 30.
Related trials for Neuromuscular Blockade
Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
Not yet recruitingObservational study
Diaphragm Ultrasound and Neuromuscular Monitoring for Predicting Early Respiratory Events After Extubation
Residual Neuromuscular Blockade, Diaphragm Dysfunction
Recruiting
Inspiratory Muscle Training and Diaphragmatic Breathing in GAD
Generalized Anxiety Disorder (GAD)
Not yet recruiting
Comparative Effects Of Exercises Targeting Upper Trapezius In Patients With Non Specific Neck Pain
Non Specific Neck Pain
RecruitingObservational study
The Association Between Residual Neuromuscular Block Risk Prediction Score and the Train-of-Four Ratio
Muscle Relaxants
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.
Casper C Kjær, MD principal investigator
Dep. of anaesthesia 4231, Rigshospitalet
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, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 4 inclusion and 5 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 18 Apr 2008. 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 Denmark. 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?
Precision at the contralateral arms using the average residual coefficient of variation over subsequent linear regressions (detrending) over time. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00472121, which also lists 1 linked publication.
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 18 Apr 2008.