Neuromuscular BlockadePhase 4NCT00226018
Performance of Acceleromyography With and Without Preload
A Phase 4 study testing Hand Adapter (Organon, Oss, the Netherlands) in people with Neuromuscular Blockade, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The purpose of this study is to examine the precision, bias and limits of agreement when monitoring the neuromuscular block with acceleromyography with and without preload and compare the method to the gold standard, mechanomyography. 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?
- Hand Adapter (Organon, Oss, the Netherlands)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2005to Oct 2006
- 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
- General anesthesia > 1 hour
- Surgery under supine position with possibility of monitoring the neuromuscular block in both arms (thumbs)
- 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 anesthesia
- Body weight less or exceeding 20% of the ideal body weight
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dep. of anesthesia, HOC, Rigshospitalet
Copenhagen, Copenhagen Ø, 2100
About this study
Official title: Performance of Acceleromyography With and Without Preload During Neuromuscular Blockade
The purpose of this study is to examine the precision, bias and limits of agreement when monitoring the neuromuscular block with acceleromyography with and without preload and compare the method to the gold standard, mechanomyography.
- Conditions
- Neuromuscular Blockade
- Being tested
- Hand Adapter (Organon, Oss, the Netherlands), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand Adapter (Organon, Oss, the Netherlands)Device
Randomization of acceleromyography with or without Hand Adapter to dominant or non-dominant arm. Contralateral neuromuscular transmission is measured with mechanomyography (The gold standard of neuromuscular monitoring)
PlaceboDevice
placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Acceleromyography with Hand Adapter on dominant arm Receives: Device: Hand Adapter (Organon, Oss, the Netherlands) |
| 2 | Active comparator | Acceleromyography with Hand Adapter on non-dominant arm Receives: Device: Hand Adapter (Organon, Oss, the Netherlands) |
| 3 | Placebo comparator | Acceleromyography without Hand Adapter on dominant arm Receives: Device: Placebo |
| 4 | Placebo comparator | Acceleromygraphy without Hand Adapter on non-dominant arm Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The precision of acceleromyography with and without preload during recovery
Secondary outcomes (11)
Bias and limits of agreement for acceleromyography (AMG) with and without preload compared to mechanomyography (MMG) during recovery
All the following outcomes obtained with AMG with and without preload are compared to MMG. Furthermore the responses are compared when the AMG-values are "normalized":
Bias og limits of agreement between control TOF
Onset time
Time to reappearance of T1, T2, T3 and T4
Twitch height of T1 at reappearance of T1, T2, T3 and T4
Time to T1=25%
Interval 25-75%
Time to TOF-ratio = 0.9 and 1.0
Time to final T1
Time to final TOF ratio
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2005 (estimated)
- Study startMar 2005
- Study completionOct 2006
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
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Investigators
- Casper C Kjaer, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00226018
- Sponsor's protocol ID
- AMG01
- Status last verified
- Apr 2008
- First submitted
- 22 Sep 2005
- 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
- Performance of Acceleromyography With and Without Preload During Neuromuscular Blockade
- ClinicalTrials.gov ID
- NCT00226018
- Acronym / sponsor ID
- AMG01
- Conditions
- Neuromuscular Blockade
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Mar 2005
- Study completion
- Oct 2006
- First posted
- 26 Sep 2005 (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 is to examine the precision, bias and limits of agreement when monitoring the neuromuscular block with acceleromyography with and without preload and compare the method to the gold standard, mechanomyography.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Hand Adapter (Organon, Oss, the Netherlands)Acceleromyography with Hand Adapter on dominant arm |
| 2 | Active comparator | Device: Hand Adapter (Organon, Oss, the Netherlands)Acceleromyography with Hand Adapter on non-dominant arm |
| 3 | Placebo comparator | Device: PlaceboAcceleromyography without Hand Adapter on dominant arm |
| 4 | Placebo comparator | Device: PlaceboAcceleromygraphy without Hand Adapter on non-dominant arm |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA I-III
- General anesthesia > 1 hour
- Surgery under supine position with possibility of monitoring the neuromuscular block in both arms (thumbs)
- 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 anesthesia
- Body weight less or exceeding 20% of the 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 |
|---|---|---|
| Hand Adapter (Organon, Oss, the Netherlands)Randomization of acceleromyography with or without Hand Adapter to dominant or non-dominant arm. Contralateral neuromuscular transmission is measured with mechanomyography (The gold standard of neuromuscular monitoring) | Device | 1, 2 |
| Placeboplacebo | Device | 3, 4 |
Primary outcome
The precision of acceleromyography with and without preload during recovery
11 secondary outcomes
Bias and limits of agreement for acceleromyography (AMG) with and without preload compared to mechanomyography (MMG) during recovery
All the following outcomes obtained with AMG with and without preload are compared to MMG. Furthermore the responses are compared when the AMG-values are "normalized":
Bias og limits of agreement between control TOF
Onset time
Time to reappearance of T1, T2, T3 and T4
Twitch height of T1 at reappearance of T1, T2, T3 and T4
Time to T1=25%
Interval 25-75%
Time to TOF-ratio = 0.9 and 1.0
Time to final T1
Time to final TOF ratio
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 C Kjaer, 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 Hand Adapter (Organon, Oss, the Netherlands) 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 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 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. Some participants in this study may receive a placebo. 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?
The precision of acceleromyography with and without preload during recovery. 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.