Neuromuscular BlockadeNCT05294523
Rocuronium and Supramaximal Stimulation
A study testing Rocuronium priming dose in people with Neuromuscular Blockade, run by Taipei Medical University Hospital at 1 site in Taiwan.
Trial summary
To shorten induction time, some anesthesiologist gives a priming dose of muscle relaxant before starting Neuromuscular Transmission monitor (NMT). To properly evaluate neuromuscular function during the surgury, baseline supramaximal stimulation of the monitored nerve is mandatory. 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?
- Rocuronium priming dose
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Dec 2021to 31 Dec 2024
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients receiving general anesthesia and use rocuronium for induction
Who cannot join
- Muscular disease
- Peripheral neuropathy
- Difficult airway or difficult mask ventilation
- Allergy to study related medication
- Pregnant woman
- < 20-year-old or > 65-year-old
- BMI <18.5 or BMI>24.9
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Medical University Hospital
Taipei, 220
Wei Chieh LAI, MD, MPH, +886919141289, ndicy@yahoo.com.tw
About this study
Official title: Priming Dose of Rocuronium and Milliamperage Value for Supramaximal Stimulation of NeuroMuscular Transmission Monitor
To shorten induction time, some anesthesiologist gives a priming dose of muscle relaxant before starting Neuromuscular Transmission monitor (NMT). To properly evaluate neuromuscular function during the surgury, baseline supramaximal stimulation of the monitored nerve is mandatory. Not knowing if the priming dose of muscle relaxant affects the supramaximal stimulation current setting, The investigators designed this study to find out.
Read the detailed description
The NMT monitor module automatically determines the current needed for the supramaximal stimulus, and maintains this current throughout the procedure.
The supramaximal current is the current above which there is no increase in the evoked muscle response. At this stimulus current, all motor units are firing in response to nerve stimulation. According to previous studies, the current was significantly increased in the presence of edema and peripheral neuropathy. In this study, the route of administration, dosage, dosage regimen, and treatment period are basically the same as the investigators anesthesia department's routine procedure for general anesthesia. The difference will be the time the investigators set between the priming dose to final dose of rocuronium is 2 minutes. The investigators use 2 minutes as the peak effect of rocuronium is 105±36S.
To properly evaluate neuromuscular blockade during the surgery, baseline supramaximal stimulation of the monitored nerve is mandatory. Not knowing if the priming dose of muscle relaxant affects the supramaximal stimulation current setting, the investigators designed this study.
- Conditions
- Neuromuscular Blockade
- Being tested
- Rocuronium priming dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rocuronium priming doseProcedure or surgery
Add the priming dose of rocuronium after the first supramaximal stimulation data measured
| Study group | Role | What they receive |
|---|---|---|
| Rocuronium priming dose 0.06mg/kg | Active comparator | Add the priming dose of rocuronium 0.06mg/kg after the first supramaximal stimulation data measured Receives: Procedure: Rocuronium priming dose |
| Rocuronium priming dose 0.12mg/kg | Active comparator | Add the priming dose of rocuronium 0.12mg/kg after the first supramaximal stimulation data measured Receives: Procedure: Rocuronium priming dose |
| Rocuronium priming dose 0.18mg/kg | Active comparator | Add the priming dose of rocuronium 0.18mg/kg after the first supramaximal stimulation data measured Receives: Procedure: Rocuronium priming dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Supramaximal stimulation value
whether the supramaximal stimulation changs after 2 minutes of priming dose of muscle relaxant use
Measured: since general anesthesia induction to endotracheal tube intubation, about 10 minutes
Secondary outcomes (4)
supramaximal stimulation value change by time
whether the supramaximal stimulation changs have a trend
Measured: since general anesthesia induction to endotracheal tube intubation, about 10 minutes
dose of rocuronium
whether the change of supramaximal stimulation change is muscle relaxant dose responsive
Measured: since general anesthesia induction to endotracheal tube intubation, about 10 minutes
Time to intubation
how long does it take from the full dose of muslce relaxant given to TOF count <2
Measured: since general anesthesia induction to endotracheal tube intubation, about 10 minutes
Intubation condition
the intubation condition with priming method used. Evaluate with scoring scale. scale range from 0-3. 0 presented as poor Jaw relaxation, closed vocal cord, and severe cough or bucking when intubation; to 3 represent a condition with good jaw relaxation, open vocal cord, and no repsponse to stimulation.
Measured: since general anesthesia induction to endotracheal tube intubation, about 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start20 Dec 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Chieh Lai, Taipei Medical University Hospital
- Investigators
- Wei Chieh Lai, MD, MPH, Study chair, Taipei Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05294523
- Sponsor's protocol ID
- N202109050
- Status last verified
- Nov 2022
- First submitted
- 31 Jan 2022
- Last updated
- 29 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: de-identified raw data
Publications
Kopman AF, Lawson D. Milliamperage requirements for supramaximal stimulation of the ulnar nerve with surface electrodes. Anesthesiology. 1984 Jul;61(1):83-5. No abstract available.
PubMed 6742488Naguib M, Brull SJ, Kopman AF, Hunter JM, Fulesdi B, Arkes HR, Elstein A, Todd MM, Johnson KB. Consensus Statement on Perioperative Use of Neuromuscular Monitoring. Anesth Analg. 2018 Jul;127(1):71-80. doi: 10.1213/ANE.0000000000002670.
PubMed 29200077Armendariz-Buil I, Lobato-Solores F, Aguilera-Celorrio L, Morros-Diaz E, Fraile-Jimenez E, Vera-Bella J. Residual neuromuscular block in type II diabetes mellitus after rocuronium: a prospective observational study. Eur J Anaesthesiol. 2014 Aug;31(8):411-6. doi: 10.1097/01.EJA.0000435022.91954.8d.
PubMed 24201596Fuchs-Buder T, Claudius C, Skovgaard LT, Eriksson LI, Mirakhur RK, Viby-Mogensen J; 8th International Neuromuscular Meeting. Good clinical research practice in pharmacodynamic studies of neuromuscular blocking agents II: the Stockholm revision. Acta Anaesthesiol Scand. 2007 Aug;51(7):789-808. doi: 10.1111/j.1399-6576.2007.01352.x.
PubMed 17635389
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Priming Dose of Rocuronium and Milliamperage Value for Supramaximal Stimulation of NeuroMuscular Transmission Monitor
- ClinicalTrials.gov ID
- NCT05294523
- Acronym / sponsor ID
- N202109050
- Conditions
- Neuromuscular Blockade
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Taipei Medical University HospitalUniversity, hospital or other
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 24 Mar 2022 (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.
To shorten induction time, some anesthesiologist gives a priming dose of muscle relaxant before starting Neuromuscular Transmission monitor (NMT). To properly evaluate neuromuscular function during the surgury, baseline supramaximal stimulation of the monitored nerve is mandatory. Not knowing if the priming dose of muscle relaxant affects the supramaximal stimulation current setting, The investigators designed this study to find out.
Detailed description
The NMT monitor module automatically determines the current needed for the supramaximal stimulus, and maintains this current throughout the procedure.
The supramaximal current is the current above which there is no increase in the evoked muscle response. At this stimulus current, all motor units are firing in response to nerve stimulation. According to previous studies, the current was significantly increased in the presence of edema and peripheral neuropathy. In this study, the route of administration, dosage, dosage regimen, and treatment period are basically the same as the investigators anesthesia department's routine procedure for general anesthesia. The difference will be the time the investigators set between the priming dose to final dose of rocuronium is 2 minutes. The investigators use 2 minutes as the peak effect of rocuronium is 105±36S.
To properly evaluate neuromuscular blockade during the surgery, baseline supramaximal stimulation of the monitored nerve is mandatory. Not knowing if the priming dose of muscle relaxant affects the supramaximal stimulation current setting, the investigators designed this study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rocuronium priming dose 0.06mg/kg | Active comparator | Procedure: Rocuronium priming doseAdd the priming dose of rocuronium 0.06mg/kg after the first supramaximal stimulation data measured |
| Rocuronium priming dose 0.12mg/kg | Active comparator | Procedure: Rocuronium priming doseAdd the priming dose of rocuronium 0.12mg/kg after the first supramaximal stimulation data measured |
| Rocuronium priming dose 0.18mg/kg | Active comparator | Procedure: Rocuronium priming doseAdd the priming dose of rocuronium 0.18mg/kg after the first supramaximal stimulation data measured |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients receiving general anesthesia and use rocuronium for induction
Key exclusion criteria (7 listed)
- Muscular disease
- Peripheral neuropathy
- Difficult airway or difficult mask ventilation
- Allergy to study related medication
- Pregnant woman
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 |
|---|---|---|
| Rocuronium priming doseAdd the priming dose of rocuronium after the first supramaximal stimulation data measured | Procedure or surgery | Rocuronium priming dose 0.06mg/kg, Rocuronium priming dose 0.12mg/kg, Rocuronium priming dose 0.18mg/kg |
Primary outcome
Supramaximal stimulation value
Time frame: since general anesthesia induction to endotracheal tube intubation, about 10 minutes
whether the supramaximal stimulation changs after 2 minutes of priming dose of muscle relaxant use
4 secondary outcomes
supramaximal stimulation value change by time
Time frame: since general anesthesia induction to endotracheal tube intubation, about 10 minutes
dose of rocuronium
Time frame: since general anesthesia induction to endotracheal tube intubation, about 10 minutes
Time to intubation
Time frame: since general anesthesia induction to endotracheal tube intubation, about 10 minutes
Intubation condition
Time frame: since general anesthesia induction to endotracheal tube intubation, about 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
- Background: PubMed 6742488Kopman AF, Lawson D. Milliamperage requirements for supramaximal stimulation of the ulnar nerve with surface electrodes. Anesthesiology. 1984 Jul;61(1):83-5. No abstract available.
- Background: PubMed 29200077Naguib M, Brull SJ, Kopman AF, Hunter JM, Fulesdi B, Arkes HR, Elstein A, Todd MM, Johnson KB. Consensus Statement on Perioperative Use of Neuromuscular Monitoring. Anesth Analg. 2018 Jul;127(1):71-80. doi: 10.1213/ANE.0000000000002670.
- Background: PubMed 24201596Armendariz-Buil I, Lobato-Solores F, Aguilera-Celorrio L, Morros-Diaz E, Fraile-Jimenez E, Vera-Bella J. Residual neuromuscular block in type II diabetes mellitus after rocuronium: a prospective observational study. Eur J Anaesthesiol. 2014 Aug;31(8):411-6. doi: 10.1097/01.EJA.0000435022.91954.8d.
- Background: PubMed 17635389Fuchs-Buder T, Claudius C, Skovgaard LT, Eriksson LI, Mirakhur RK, Viby-Mogensen J; 8th International Neuromuscular Meeting. Good clinical research practice in pharmacodynamic studies of neuromuscular blocking agents II: the Stockholm revision. Acta Anaesthesiol Scand. 2007 Aug;51(7):789-808. doi: 10.1111/j.1399-6576.2007.01352.x.
- Diabetes Mellitus and Neuromuscular Blockade: ReviewLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. de-identified raw data
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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.
Wei Chieh Lai, MD, MPH study chair
Taipei Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rocuronium priming dose in people with Neuromuscular Blockade, run by Taipei Medical University Hospital at 1 site in Taiwan.
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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 29 Nov 2022. 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 Taiwan. 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 Wei Chieh Lai, MD, MPH (+886919141289, ndicy@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Supramaximal stimulation value (time frame: since general anesthesia induction to endotracheal tube intubation, about 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05294523, which also lists 4 linked publications.
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 29 Nov 2022.