Neuromuscular BlockadeNCT03660891
OS NMB Depth Measured by Central and Peripheral Monitor.
An observational study of Neuromuscular Blockade, run by AZ Sint-Jan AV at 1 site in Belgium.
Trial summary
Comparing during anesthesia in the same patient 2 neuromuscular monitors on the same arm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromuscular Blockade
- What is being tested?
- measuring neuromuscular block
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Aug 2020to 31 Dec 2021
- 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
- No healthy volunteers
- Adult, Older adult
Study population: all patients undergo a laparoscopic surgery and require a deep NMB.
Inclusion Criteria: all patients scheduled for an elective surgery requiring neuromuscular block during anesthesia
- laparoscopic surgery of upper abdomen including all types of bariatric surgery.
Exclusion Criteria: not possible to measure NMT (neuromuscular transmission) by cuff or thumb monitor
- upper arm obesity excluding the use of an upper arm blood pressure cuff
- allergy to NMB (neuromuscular blockers)
- contra indication for a deep NMB
Trial locations and contacts
1 site in 1 country.
Kris Leleu, MD contact
Belgium1 site
Azsintjan
Bruges, 8000
j p mulier, MD PhD, 00 32 50 45 21 93, anesthesie@azsintjan.be
jan P mulier, PhD
About this study
Official title: Observational Study Measuring Neuromuscular Block Depth by a TOF or PTC Monitor on the Thumb and on the Upper Arm of the Same Side.
Comparing during anesthesia in the same patient 2 neuromuscular monitors on the same arm.
Read the detailed description
NMT (neuromuscular transmission) depth can be measured at the same arm with two different methods during clinical practice.
the first (TOF Watch) measures the musculus adductor pollicis acceleration while the second method (TOF Cuff Monitor) uses a blood pressure cuff to measure the pressure changes induced by the upper arm muscles.
During general anesthesia when NMB (neuromuscular block) is required both methods are used. Every 5 minutes, if clinical required, the NMB is monitored by TOF-PTC. If the measurement of TOF is zero the monitor continues by measuring PTC ( the system will measure TOF followed by PTC if TOF is zero) TOF-PTC is recorded and later compared for identity or systematic difference in one or the other direction.
The measured answer can be TOF 4 (4 answers) with a ratio between answer 1 and 4 expressed and a percentage, TOF 3 (3 answers), TOF 2, TOF 1, TOF 0 + PTC 20, TOF 0 + PTC 19, up to TOF 0 + PTC 0
- Conditions
- Neuromuscular Blockade
- Being tested
- measuring neuromuscular block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measuring neuromuscular blockDiagnostic test
During anesthesia patients are monitored with two instead of one NMT monitor. the difference in measured TOF-PTC is compared
What is being measured
The primary outcome is the main question the study is designed to answer.
TOF-PTC value
Difference in TOF-PTC measured by two different devices during anesthesia.
Measured: From induction of anesthesia (intubation with ETT) till end of anesthesia (extubation of ETT) most frequent between 1 and 2 hours, max 6 hours in duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start1 Aug 2020 (estimated)
- Primary completion30 Dec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AZ Sint-Jan AV
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Mulier, AZ Sint-Jan AV
- Investigators
- Jan Paul Mulier, Principal investigator, AZSint Jan AV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03660891
- Sponsor's protocol ID
- OS NMBcentralperipheral
- Status last verified
- Mar 2020
- First submitted
- 19 Aug 2018
- Last updated
- 23 Mar 2020
- 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 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study Measuring Neuromuscular Block Depth by a TOF or PTC Monitor on the Thumb and on the Upper Arm of the Same Side.
- ClinicalTrials.gov ID
- NCT03660891
- Acronym / sponsor ID
- OS NMBcentralperipheral
- Conditions
- Neuromuscular Blockade
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- AZ Sint-Jan AVUniversity, hospital or other
- Study start
- 1 Aug 2020 (estimated)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 7 Sep 2018 (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.
Comparing during anesthesia in the same patient 2 neuromuscular monitors on the same arm.
Detailed description
NMT (neuromuscular transmission) depth can be measured at the same arm with two different methods during clinical practice.
the first (TOF Watch) measures the musculus adductor pollicis acceleration while the second method (TOF Cuff Monitor) uses a blood pressure cuff to measure the pressure changes induced by the upper arm muscles.
During general anesthesia when NMB (neuromuscular block) is required both methods are used. Every 5 minutes, if clinical required, the NMB is monitored by TOF-PTC. If the measurement of TOF is zero the monitor continues by measuring PTC ( the system will measure TOF followed by PTC if TOF is zero) TOF-PTC is recorded and later compared for identity or systematic difference in one or the other direction.
The measured answer can be TOF 4 (4 answers) with a ratio between answer 1 and 4 expressed and a percentage, TOF 3 (3 answers), TOF 2, TOF 1, TOF 0 + PTC 20, TOF 0 + PTC 19, up to TOF 0 + PTC 0
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patients undergo a laparoscopic surgery and require a deep NMB.
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 |
|---|---|---|
| measuring neuromuscular blockDuring anesthesia patients are monitored with two instead of one NMT monitor. the difference in measured TOF-PTC is compared | Diagnostic test | – |
Primary outcome
TOF-PTC value
Time frame: From induction of anesthesia (intubation with ETT) till end of anesthesia (extubation of ETT) most frequent between 1 and 2 hours, max 6 hours in duration
Difference in TOF-PTC measured by two different devices during anesthesia.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2020.
- 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.
Kris Leleu, MD contact
Jan Paul Mulier principal investigator
AZSint Jan AV
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 AZ Sint-Jan AV at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 23 Mar 2020. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jan Paul Mulier, PhD (003259452490, jan.mulier@azsintjan.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TOF-PTC value (time frame: From induction of anesthesia (intubation with ETT) till end of anesthesia (extubation of ETT) most frequent between 1 and 2 hours, max 6 hours in duration). 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 23 Mar 2020.