Neuromuscular BlockadePhase 4NCT00390507
Modification of Posttetanic Count (PTC) for Monitoring Deep Neuromuscular Block II
A Phase 4 study testing Post-tetanic count frequency in people with Neuromuscular Blockade, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
Trial summary
The purpose of this study is to examine the relationship between post-tetanic count (PTC) and time to first response to Train of four (TOF) stimulation during deep neuromuscular blockade induced by rocuronium. 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?
- Post-tetanic count frequency
- Type of treatment
- Surgery or procedure
- How many people
- 45 participants
- Where
- 2 sitesDenmark
- Study dates
- Oct 2006to Apr 2010
- 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 1-3
- General anaesthesia >1 hour
- Surgery in supine position with possibility of monitoring the neuromuscular blockade at the thumb (n.ulnaris stimulation).
- 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 the ideal body weight
- Pregnancy or breastfeeding
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Dep. of Anesthesia, Rigshospitalet
Copenhagen, Copenhagen, 2100
Dep. of Anesthesia, Herlev hospital
Herlev, Herlev, 2730
About this study
The purpose of this study is to examine the relationship between post-tetanic count (PTC) and time to first response to Train of four (TOF) stimulation during deep neuromuscular blockade induced by rocuronium.
- Conditions
- Neuromuscular Blockade
- Being tested
- Post-tetanic count frequency
- Keywords
- Acceleromyography, TOF-Watch, Posttetanic count, Train of four, Neuromuscular blockade
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-tetanic count frequencyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first response to TOF stimulation (T1)
Secondary outcomes (7)
Time to second response to TOF stimulation (T2)
Time to first post-tetanic count (PTC)
Number of post-tetanic count at first response to TOF
Time to T1=25%
Interval 25-75%
Time to TOF 0.9
Time to TOF 1.0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2006 (estimated)
- Study startOct 2006
- Primary completionApr 2010
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
- Single blind
- Enrolment
- 45 participants (actual)
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
- NCT00390507
- Sponsor's protocol ID
- PTC-II
- Status last verified
- Sep 2010
- First submitted
- 19 Oct 2006
- Last updated
- 6 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modification of Posttetanic Count (PTC) for Monitoring Deep Neuromuscular Block II
- ClinicalTrials.gov ID
- NCT00390507
- Acronym / sponsor ID
- PTC-II
- Conditions
- Neuromuscular Blockade
- Keywords
- Acceleromyography, TOF-Watch, Posttetanic count, Train of four, Neuromuscular blockade
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Apr 2010 (actual)
- First posted
- 20 Oct 2006 (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 relationship between post-tetanic count (PTC) and time to first response to Train of four (TOF) stimulation during deep neuromuscular blockade induced by rocuronium.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
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 1-3
- General anaesthesia >1 hour
- Surgery in supine position with possibility of monitoring the neuromuscular blockade at the thumb (n.ulnaris stimulation).
- 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 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 |
|---|---|---|
| Post-tetanic count frequency | Procedure or surgery | – |
Primary outcome
Time to first response to TOF stimulation (T1)
7 secondary outcomes
Time to second response to TOF stimulation (T2)
Time to first post-tetanic count (PTC)
Number of post-tetanic count at first response to TOF
Time to T1=25%
Interval 25-75%
Time to TOF 0.9
Time to TOF 1.0
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 6 Sep 2010.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Post-tetanic count frequency in people with Neuromuscular Blockade, run by Copenhagen University Hospital, Rigshospitalet at 2 sites 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 6 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Time to first response to TOF stimulation (T1). 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 6 Sep 2010.