Neuromuscular Blockade MonitoringNCT03146767
The Staircase Phenomenon Implications on Neuromuscular Block Monitoring
A study testing Tetanus stabilization of baseline in people with Neuromuscular Blockade Monitoring, run by Hospital Universitario La Fe at 1 site in Spain.
Trial summary
The staircase phenomenon could have repercussions on the onset and recovery time following administration of a neuromuscular blocking agent. The investigators aim to assess the magnitude of the staircase phenomenon and its impact on various aspects of neuromuscular blockade with a randomized controlled double blind… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromuscular Blockade Monitoring
- What is being tested?
- Tetanus stabilization of baseline
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2013to Mar 2014
- Phase
- Interventional
- 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
Who may be able to join
- ASA (American Society of Anesthesiology surgical risk scale) grade I - II
- Surgery not involving airway performed under general anaesthesia with neuromuscular blocker
Who cannot join
- Pregnancy
- BMI (Body Mass Idex) > 35 Kg/m2
- Anticipated difficult airway
- Chronic kidney or hepatic failure
- Neuromuscular disease
- Medication that has known interactions with neuromuscular blockers
- Hemodynamic failure
- Anticipated large blood loss
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Staircase Phenomenon and His Implications on Neuromuscular Block Monitoring During General Anesthesia
The staircase phenomenon could have repercussions on the onset and recovery time following administration of a neuromuscular blocking agent. The investigators aim to assess the magnitude of the staircase phenomenon and its impact on various aspects of neuromuscular blockade with a randomized controlled double blind trial.
- Conditions
- Neuromuscular Blockade Monitoring
- Being tested
- Tetanus stabilization of baseline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tetanus stabilization of baselineDevice
Administering a Tetanic stimulus before baseline stabilization shortens the stabilization period of baseline of a neuromuscular block monitor. This acts on the baseline value
| Study group | Role | What they receive |
|---|---|---|
| Tetanic Group | Experimental | A Tetanic stimulation (Tetanus stabilization of baseline) is administered to the monitorized arm before calibrating the neuromuscular block monitor. Then Train-of-four (TOF) stimuli are administered every 20 seconds for 20 minutes. Receives: Device: Tetanus stabilization of baseline |
| Control Group | No intervention | Conventional monitor baseline stabilization: Train-of-four stimuli are administered every 20 seconds for 20 minutes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Block Onset time difference (seconds)
Onset time is the time between Train of Four (TOF) at the moment of injection of neuromuscular blocking drug and the minimum value reached (onset of neuromuscular block)
Measured: rom 0 seconds up to 240 seconds after neuromuscular block administration at the beginning of surgery. Time frame is the duration of general anesthesia before, during and after surgery (up to 4 hours).
Secondary outcomes (11)
Difference in time until recovery of a TOF ratio (TOFr) of 0.9
Time until recovery of a TOF ratio of 0.9 (reversal of neuromuscular block as assessed by the monitor). During recovery phase stimuli regain height until all four stimuli of the Train-of-Four are present. Train-of-Four ratio is the ratio between the fourth and the first stimuli (T4/T1).
Measured: From administration of neuromuscular blocking drug until spontaneous reversal (up to 4 hours). Time frame is the duration of general anesthesia before, during and after surgery (up to 4 hours).
Difference in TOFr 0.9 Normalized
Time until recovery of a TOF ratio of 0.9 normalized to baseline TOR ratio after calibration. (e.g. if baseline TOF ratio is 1.1, normalized TOF ratio 0.9 is: 1.1 x 0.9 = 0.99)
Measured: From administration of neuromuscular blocking drug until spontaneous reversal at this specified point (up to 4 hours). Time frame is the duration of general anesthesia before, during and after surgery (up to 4 hours).
Difference in time until recovery of 25% of maximum twitch height ot T1 stimulus (DUR25)
Difference in time until recovery of 25% of maximum twitch height ot T1 stimulus during recovery phase. During recovery phase stimuli begin to recover and their height increases. This outcome is the time between the beginning of neuromuscular block until recovery of 25% of height of the first stimulus of the Train-of-Four.recovery phase. During recovery phase stimuli begin to recover and their height increases. This outcome is the time between the beginning of neuromuscular block until recovery of 25% of height of the first stimulus of the Train-of-Four (TOF)
Measured: From administration of neuromuscular blocking drug until spontaneous reversal at this specified point (up to 4 hours). Time frame is the duration of general anesthesia before, during and after surgery.(up to 4 hours)
Time between 25% and 75% of maximum twitch height recovery of T1 stimulus
Time between 25% and 75% height recovery of maximum twitch height in the recovery phase.
Measured: From administration of neuromuscular blocking drug until spontaneous reversal (up to 4 hours). Time frame is the duration of general anesthesia before, during and after surgery (up to 4 hours).
Difference between first stimulus of Train-of-Four ratio at baseline
Difference between T1 at baseline. Train-of-Four ratio is the administration of four consecutive stimuli to the monitored muscle. These stimuli are named T1,T2,T3,T4. This is the difference between tow arms oh T1 height at baseline
Measured: Single measurement of muscle response after calibration procedure at the beginning of data recording after randomization. It is not a time-to-event variable
Difference between T1 height after stabilization period of 20 minutes
Difference between T1 height after stabilization period of 20 minutes
Measured: Single measurement after 20 minutes stabilization period after beginning of neuromuscular stimulation. It is not a time-to-event variable
Difference between TOF ratio at baseline time
Difference between TOF ratio at baseline time
Measured: Single measurement of muscle response after calibration procedure at the beginning of data recording.
Difference between TOF ratio after stabilization period time
Difference between TOF ratio after stabilization period time
Measured: Single measurement after 20 minutes stabilization period after beginning of neuromuscular stimulation.
Monitor Sensitivity difference between groups
Sensitivity parameter is set by monitor after calibration.
Measured: Single value no time frame. Sensitivity is internally set by the monitor during calibration (at the beginning of data recording after randomization)
Monitor Amperage Intensity after calibration difference (milliAmperes, mA)
Monitor Amperage Intensity is set by the monitor after calibration
Measured: Single value no time frame. Sensitivity is internally set by the monitor during calibration (at the beginning of data recording after randomization)
T1/TOFratio relationship difference
During recovery phase T1 over TOF ratio will be calculated and the difference between two groups will be assessed.
Measured: Ratio of specified values recorded by the monitor at the beginning of surgery until onset of neuromuscular block (up to 180 seconds) and during spontaneous recovery up to 4 hours until end of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study startFeb 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular Blockade MonitoringStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Fe
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oscar Diaz-Cambronero, Hospital Universitario La Fe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03146767
- Sponsor's protocol ID
- MAZ0816
- Status last verified
- May 2017
- First submitted
- 25 Apr 2017
- Last updated
- 10 May 2017
- Results posted
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Staircase Phenomenon and His Implications on Neuromuscular Block Monitoring During General Anesthesia
- ClinicalTrials.gov ID
- NCT03146767
- Acronym / sponsor ID
- MAZ0816
- Conditions
- Neuromuscular Blockade Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hospital Universitario La FeUniversity, hospital or other
- Study start
- Feb 2013 (actual)
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 10 May 2017 (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.
The staircase phenomenon could have repercussions on the onset and recovery time following administration of a neuromuscular blocking agent. The investigators aim to assess the magnitude of the staircase phenomenon and its impact on various aspects of neuromuscular blockade with a randomized controlled double blind trial.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tetanic Group | Experimental | Device: Tetanus stabilization of baselineA Tetanic stimulation (Tetanus stabilization of baseline) is administered to the monitorized arm before calibrating the neuromuscular block monitor. Then Train-of-four (TOF) stimuli are administered every 20 seconds for 20 minutes. |
| Control Group | No intervention | –Conventional monitor baseline stabilization: Train-of-four stimuli are administered every 20 seconds for 20 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA (American Society of Anesthesiology surgical risk scale) grade I - II
- Surgery not involving airway performed under general anaesthesia with neuromuscular blocker
Key exclusion criteria (8 listed)
- Pregnancy
- BMI (Body Mass Idex) > 35 Kg/m2
- Anticipated difficult airway
- Chronic kidney or hepatic failure
- Neuromuscular disease
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 |
|---|---|---|
| Tetanus stabilization of baselineAdministering a Tetanic stimulus before baseline stabilization shortens the stabilization period of baseline of a neuromuscular block monitor. This acts on the baseline value | Device | Tetanic Group |
Primary outcome
Difference in Block Onset time difference (seconds)
Time frame: rom 0 seconds up to 240 seconds after neuromuscular block administration at the beginning of surgery. Time frame is the duration of general anesthesia before, during and after surgery (up to 4 hours).
Onset time is the time between Train of Four (TOF) at the moment of injection of neuromuscular blocking drug and the minimum value reached (onset of neuromuscular block)
11 secondary outcomes
Difference in time until recovery of a TOF ratio (TOFr) of 0.9
Time frame: From administration of neuromuscular blocking drug until spontaneous reversal (up to 4 hours). Time frame is the duration of general anesthesia before, during and after surgery (up to 4 hours).
Difference in TOFr 0.9 Normalized
Time frame: From administration of neuromuscular blocking drug until spontaneous reversal at this specified point (up to 4 hours). Time frame is the duration of general anesthesia before, during and after surgery (up to 4 hours).
Difference in time until recovery of 25% of maximum twitch height ot T1 stimulus (DUR25)
Time frame: From administration of neuromuscular blocking drug until spontaneous reversal at this specified point (up to 4 hours). Time frame is the duration of general anesthesia before, during and after surgery.(up to 4 hours)
Time between 25% and 75% of maximum twitch height recovery of T1 stimulus
Time frame: From administration of neuromuscular blocking drug until spontaneous reversal (up to 4 hours). Time frame is the duration of general anesthesia before, during and after surgery (up to 4 hours).
Difference between first stimulus of Train-of-Four ratio at baseline
Time frame: Single measurement of muscle response after calibration procedure at the beginning of data recording after randomization. It is not a time-to-event variable
Difference between T1 height after stabilization period of 20 minutes
Time frame: Single measurement after 20 minutes stabilization period after beginning of neuromuscular stimulation. It is not a time-to-event variable
Difference between TOF ratio at baseline time
Time frame: Single measurement of muscle response after calibration procedure at the beginning of data recording.
Difference between TOF ratio after stabilization period time
Time frame: Single measurement after 20 minutes stabilization period after beginning of neuromuscular stimulation.
Monitor Sensitivity difference between groups
Time frame: Single value no time frame. Sensitivity is internally set by the monitor during calibration (at the beginning of data recording after randomization)
Monitor Amperage Intensity after calibration difference (milliAmperes, mA)
Time frame: Single value no time frame. Sensitivity is internally set by the monitor during calibration (at the beginning of data recording after randomization)
T1/TOFratio relationship difference
Time frame: Ratio of specified values recorded by the monitor at the beginning of surgery until onset of neuromuscular block (up to 180 seconds) and during spontaneous recovery up to 4 hours until end of anesthesia
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 10 May 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tetanus stabilization of baseline in people with Neuromuscular Blockade Monitoring, run by Hospital Universitario La Fe at 1 site in Spain.
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 2 inclusion and 8 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 10 May 2017. 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 Spain. 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?
Difference in Block Onset time difference (seconds) (time frame: rom 0 seconds up to 240 seconds after neuromuscular block administration at the beginning of surgery. Time frame is the duration of general anesthesia before, during and after surgery (up to 4 hours).). 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 10 May 2017.