Neuromuscular BlockadePhase 4NCT00660413
Comparison of Acceleromyography (AMG) and Mechanomyography (MMG) for Establishing Potency of Neuromuscular Blocking Agents
A Phase 4 study testing TOF-Watch SX (Acceleromyography) in people with Neuromuscular Blockade, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The purpose of this study was to compare two methods for neuromuscular monitoring, acceleromyography and mechanomyography for establishing the dose-response relationship and the potency of a neuromuscular blocking agent using rocuronium as an example. 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 (Acceleromyography)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2007to Feb 2008
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-III
- Ideal weight +/-20%
- Both arms available for neuromuscular monitoring
- Surgery in supine position
- Participated surgery time more than 30 min
Who cannot join
- Pregnant and breast-feeding women
- Patients with known illness or use of medications known to influence the neuromuscular transmission
- Known significant renal or hepatic dysfunction
- Allergy to medications used in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Acceleromyography and Mechanomyography for Establishing Potency of Neuromuscular Blocking Agents, A Randomized Controlled Study
The purpose of this study was to compare two methods for neuromuscular monitoring, acceleromyography and mechanomyography for establishing the dose-response relationship and the potency of a neuromuscular blocking agent using rocuronium as an example. We hypothesized that there would be no significant difference between potencies estimated using acceleromyography and mechanomyography.
- Conditions
- Neuromuscular Blockade
- Being tested
- TOF-Watch SX (Acceleromyography)
- Keywords
- Acceleromyography, Mechanomyography, Neuromuscular block, Neuromuscular monitoring, Dose-response, Potency, Rocuronium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOF-Watch SX (Acceleromyography)Device
Randomization of AMG to dominant or non-dominant arm. MMG at contralateral arm.
| Study group | Role | What they receive |
|---|---|---|
| AMG | Experimental | Acceleromygraphy monitoring Receives: Device: TOF-Watch SX (Acceleromyography) |
| MMG | Active comparator | Mechanomyography monitoring Receives: Device: TOF-Watch SX (Acceleromyography) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of ED50 with the two methods
Secondary outcomes (1)
Comparison of ED95 with the two methods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2008 (estimated)
- Study startDec 2007
- Primary completionFeb 2008
- Study completionFeb 2008
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.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Single blind
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Investigators
- Casper Claudius, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00660413
- Sponsor's protocol ID
- AMG-MMG D-R
- Status last verified
- Apr 2008
- First submitted
- 15 Apr 2008
- Last updated
- 17 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Acceleromyography and Mechanomyography for Establishing Potency of Neuromuscular Blocking Agents, A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT00660413
- Acronym / sponsor ID
- AMG-MMG D-R
- Conditions
- Neuromuscular Blockade
- Keywords
- Acceleromyography, Mechanomyography, Neuromuscular block, Neuromuscular monitoring, Dose-response, Potency, Rocuronium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 17 Apr 2008 (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 this study was to compare two methods for neuromuscular monitoring, acceleromyography and mechanomyography for establishing the dose-response relationship and the potency of a neuromuscular blocking agent using rocuronium as an example. We hypothesized that there would be no significant difference between potencies estimated using acceleromyography and mechanomyography.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Single blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMG | Experimental | Device: TOF-Watch SX (Acceleromyography)Acceleromygraphy monitoring |
| MMG | Active comparator | Device: TOF-Watch SX (Acceleromyography)Mechanomyography monitoring |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ASA I-III
- Ideal weight +/-20%
- Both arms available for neuromuscular monitoring
- Surgery in supine position
- Participated surgery time more than 30 min
Key exclusion criteria (4 listed)
- Pregnant and breast-feeding women
- Patients with known illness or use of medications known to influence the neuromuscular transmission
- Known significant renal or hepatic dysfunction
- Allergy to medications used in the study
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 (Acceleromyography)Randomization of AMG to dominant or non-dominant arm. MMG at contralateral arm. | Device | AMG, MMG |
Primary outcome
Comparison of ED50 with the two methods
1 secondary outcome
Comparison of ED95 with the two methods
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 17 Apr 2008.
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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.
Casper Claudius, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TOF-Watch SX (Acceleromyography) in people with 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 5 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 17 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Comparison of ED50 with the two methods. 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 17 Apr 2008.