Neuromuscular Blockade, ResidualETCETERANCT06062290
Does Electromyography Improve Precision and Reliability of Neuromuscular Monitoring in Paediatric Patients
An observational study of Neuromuscular Blockade, Residual and Postoperative Complications, run by University Hospital Ulm at 1 site in Germany.
Trial summary
Neuromuscular monitoring is used as a standard surveillance method of neuromuscular function to ensure full recovery at the end of anaesthesia. The currently available devices properly provide respective information in adults but not in children. Read more about this study
- Who is it for?
- Ages 1 hour to 5 years
- Conditions the study is for
- Neuromuscular Blockade, Residual, Postoperative Complications
- What is being tested?
- Electromyography (EMG) and Kinemyography (KMG)
- Type of treatment
- Medical device
- How many people
- 64 participants
- Where
- 1 siteGermany
- Study dates
- 20 Sep 2023to 10 Dec 2024
- 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 1 hour to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: The ETCETERA study will be performed in children <5 years of age scheduled for elective, non-cardiac surgery requiring general anaesthesia and neuromuscular blockade.
Who may be able to join
- children and infants < 5 years
- non-cardiac surgery requiring general anaesthesia and neuromuscular blockade
- signed informed written consent
- American Society of Anesthesiologists physical status <4
- intraoperative positioning with access to both arms
Who cannot join
- allergy to neuromuscular blocking agents
- allergy to neuromuscular monitoring adhesive electrode
- neurologic disease
- surgical procedures outside the operating room
- children receiving neuromuscular blocking agents immediately before surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Original Title: Does ElecTromyography Improve preCision and Reliability of nEuromuscular moniToring in paEdiatRic pAtients - A Monocentric Randomized Prospective Agreement Study - ETCETERA
Neuromuscular monitoring is used as a standard surveillance method of neuromuscular function to ensure full recovery at the end of anaesthesia. The currently available devices properly provide respective information in adults but not in children. Furthermore, response to neuromuscular blocking agents differs between adults and children due to age-related differences in body composition, physiological function, and acetylcholine receptor density.
Recently, electromyographic (EMG) technologies to monitor neuromuscular function were increasingly developed including disposables for nerve stimulation and measurement of the compound muscle action potential in children. However, it is still unclear whether the precision and reliability of these devices is superior to the currently available neuromuscular monitoring for children based on kinemyography (KMG).
The ETCETERA study will test the hypothesis that neither EMG nor KMG provides inferior train-of-four readings to the respective reference method in infants and children below five years.
Read the detailed description
The ETCETERA trial is a randomized clinical agreement study which will prospectively enrol sixty-four children below five years of age scheduled for elective, non-cardiac surgery requiring general anaesthesia and neuromuscular blockade for optimisation of surgical conditions.
The children's neuromuscular function is measured on one hand with EMG and on the other hand with KMG in a randomised fashion. Additionally, randomisation will be stratified upon age groups: 1) neonates: birth to <28 days, 2) infants 28 days to ≤3 months, 3) toddlers: >3 months to ≤2 years, 4) children >2 years to <5 years.
Based on the high failure rate of currently available neuromuscular monitoring devices in infants and neonates, in this randomised agreement study we will primarily compare precision and reliability of EMG and KMG-measured Train-of-Four (TOF) values during spontaneous recovery from a rocuronium-induced neuromuscular blockade in neonates, infants, toddlers, and children <5 years using the age-appropriate paediatric sensors.
- Being tested
- Electromyography (EMG), Kinemyography (KMG)
- Keywords
- Electromyography, Neuromuscular Blockade, Postoperative Complications
- Medical subject headings
- Delayed Emergence from Anesthesia, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electromyography (EMG)Device
Measurement of the compound muscle action potential for the assessment of neuromuscular function
Kinemyography (KMG)Device
Measurement of the muscle velocity for the assessment of neuromuscular function
| Study group | Role | What they receive |
|---|---|---|
| neonates | birth to <28 days Receives: Device: Electromyography (EMG); Device: Kinemyography (KMG) | |
| infants | 28 days to ≤3 months Receives: Device: Electromyography (EMG); Device: Kinemyography (KMG) | |
| toddlers | >3 months to ≤2 years Receives: Device: Electromyography (EMG); Device: Kinemyography (KMG) | |
| children | >2 years to <5 years Receives: Device: Electromyography (EMG); Device: Kinemyography (KMG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Precision of TOF (train of four) measurements
The primary endpoint is the repeatability coefficient "r" defined as 1.96 times the standard deviation of the differences between two consecutive TOF ratio measurements on the same patient under identical conditions.
The repeatability coefficient and its confidence intervals will be calculated using a linear mixed regression model for EMG and KMG measured TOF ratios independently at baseline and at complete neuromuscular recovery, i.e., at TOF ratio > 0.9 and compared between techniques using F-tests with a non-inferiority approach.
Measured: intraoperatively
Secondary outcomes (1)
Agreement of TOF values during spontaneous recovery of neuromuscular function
Agreement of TOF during spontaneous recovery of neuromuscular function, agreement of TOF at baseline and agreement of the final TOF at >0.9 and 1.0 will be verified.
The repeatability coefficient and its confidence intervals will be calculated using a linear mixed regression model for EMG and KMG measured TOF ratios independently at baseline and at complete neuromuscular recovery, i.e., at TOF ratio > 0.9 and compared between techniques using F-tests with a non-inferiority approach.
Measured: intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start20 Sep 2023
- Primary completion10 May 2024
- Study completion10 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular Blockade, ResidualStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Ulm
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Flora Scheffenbichler, University Hospital Ulm
- Investigators
- Flora Scheffenbichler, MD, Principal investigator, Department of Anesthesiology and Intensive Care Medicine, University of Ulm, Ulm, Germany.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06062290
- Sponsor's protocol ID
- ETCETERA
- Acronym
- ETCETERA
- Status last verified
- Sep 2024
- First submitted
- 15 Aug 2023
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Buttner W, Finke W, Hilleke M, Reckert S, Vsianska L, Brambrink A. [Development of an observational scale for assessment of postoperative pain in infants]. Anasthesiol Intensivmed Notfallmed Schmerzther. 1998 Jun;33(6):353-61. doi: 10.1055/s-2007-994263. German.
PubMed 9689392Murphy GS, Szokol JW, Marymont JH, Greenberg SB, Avram MJ, Vender JS. Residual neuromuscular blockade and critical respiratory events in the postanesthesia care unit. Anesth Analg. 2008 Jul;107(1):130-7. doi: 10.1213/ane.0b013e31816d1268.
PubMed 18635478Scheffenbichler FT, Marb M, Ulm B, Scholze AS, Bode SFN, Jungwirth B, Blobner M, Schmid S. Precision of neuromuscular monitoring in paediatric patients: a randomised prospective agreement study of kinemyography and electromyography. Br J Anaesth. 2026 Jul 31:S0007-0912(26)00473-3. doi: 10.1016/j.bja.2026.06.016. Online ahead of print.
PubMed 42538250
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Original Title: Does ElecTromyography Improve preCision and Reliability of nEuromuscular moniToring in paEdiatRic pAtients - A Monocentric Randomized Prospective Agreement Study - ETCETERA
- ClinicalTrials.gov ID
- NCT06062290
- Acronym / sponsor ID
- ETCETERA / ETCETERA
- Keywords
- Electromyography, Neuromuscular Blockade, Postoperative Complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University Hospital UlmUniversity, hospital or other
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- 10 May 2024 (actual)
- Study completion
- 10 Dec 2024 (estimated)
- First posted
- 2 Oct 2023 (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.
Neuromuscular monitoring is used as a standard surveillance method of neuromuscular function to ensure full recovery at the end of anaesthesia. The currently available devices properly provide respective information in adults but not in children. Furthermore, response to neuromuscular blocking agents differs between adults and children due to age-related differences in body composition, physiological function, and acetylcholine receptor density.
Recently, electromyographic (EMG) technologies to monitor neuromuscular function were increasingly developed including disposables for nerve stimulation and measurement of the compound muscle action potential in children. However, it is still unclear whether the precision and reliability of these devices is superior to the currently available neuromuscular monitoring for children based on kinemyography (KMG).
The ETCETERA study will test the hypothesis that neither EMG nor KMG provides inferior train-of-four readings to the respective reference method in infants and children below five years.
Detailed description
The ETCETERA trial is a randomized clinical agreement study which will prospectively enrol sixty-four children below five years of age scheduled for elective, non-cardiac surgery requiring general anaesthesia and neuromuscular blockade for optimisation of surgical conditions.
The children's neuromuscular function is measured on one hand with EMG and on the other hand with KMG in a randomised fashion. Additionally, randomisation will be stratified upon age groups: 1) neonates: birth to <28 days, 2) infants 28 days to ≤3 months, 3) toddlers: >3 months to ≤2 years, 4) children >2 years to <5 years.
Based on the high failure rate of currently available neuromuscular monitoring devices in infants and neonates, in this randomised agreement study we will primarily compare precision and reliability of EMG and KMG-measured Train-of-Four (TOF) values during spontaneous recovery from a rocuronium-induced neuromuscular blockade in neonates, infants, toddlers, and children <5 years using the age-appropriate paediatric sensors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| neonates | – | Device: Electromyography (EMG), Device: Kinemyography (KMG)birth to <28 days |
| infants | – | Device: Electromyography (EMG), Device: Kinemyography (KMG)28 days to ≤3 months |
| toddlers | – | Device: Electromyography (EMG), Device: Kinemyography (KMG)>3 months to ≤2 years |
| children | – | Device: Electromyography (EMG), Device: Kinemyography (KMG)>2 years to <5 years |
Who may qualify
- Ages
- 1 hour to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The ETCETERA study will be performed in children <5 years of age scheduled for elective, non-cardiac surgery requiring general anaesthesia and neuromuscular blockade.
Key inclusion criteria (5 listed)
- children and infants < 5 years
- non-cardiac surgery requiring general anaesthesia and neuromuscular blockade
- signed informed written consent
- American Society of Anesthesiologists physical status <4
- intraoperative positioning with access to both arms
Key exclusion criteria (5 listed)
- allergy to neuromuscular blocking agents
- allergy to neuromuscular monitoring adhesive electrode
- neurologic disease
- surgical procedures outside the operating room
- children receiving neuromuscular blocking agents immediately before surgery
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 |
|---|---|---|
| Electromyography (EMG)Measurement of the compound muscle action potential for the assessment of neuromuscular function | Device | children, infants, neonates, toddlers |
| Kinemyography (KMG)Measurement of the muscle velocity for the assessment of neuromuscular function | Device | children, infants, neonates, toddlers |
Primary outcome
Precision of TOF (train of four) measurements
Time frame: intraoperatively
The primary endpoint is the repeatability coefficient "r" defined as 1.96 times the standard deviation of the differences between two consecutive TOF ratio measurements on the same patient under identical conditions. The repeatability coefficient and its confidence intervals will be calculated using a linear mixed regression model for EMG and KMG measured TOF ratios independently at baseline and at complete neuromuscular recovery, i.e., at TOF ratio > 0.9 and compared between techniques using F-tests with a non-inferiority approach.
1 secondary outcome
Agreement of TOF values during spontaneous recovery of neuromuscular function
Time frame: intraoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Background: PubMed 9689392Buttner W, Finke W, Hilleke M, Reckert S, Vsianska L, Brambrink A. [Development of an observational scale for assessment of postoperative pain in infants]. Anasthesiol Intensivmed Notfallmed Schmerzther. 1998 Jun;33(6):353-61. doi: 10.1055/s-2007-994263. German.
- Background: PubMed 18635478Murphy GS, Szokol JW, Marymont JH, Greenberg SB, Avram MJ, Vender JS. Residual neuromuscular blockade and critical respiratory events in the postanesthesia care unit. Anesth Analg. 2008 Jul;107(1):130-7. doi: 10.1213/ane.0b013e31816d1268.
- Derived from this study: PubMed 42538250Scheffenbichler FT, Marb M, Ulm B, Scholze AS, Bode SFN, Jungwirth B, Blobner M, Schmid S. Precision of neuromuscular monitoring in paediatric patients: a randomised prospective agreement study of kinemyography and electromyography. Br J Anaesth. 2026 Jul 31:S0007-0912(26)00473-3. doi: 10.1016/j.bja.2026.06.016. Online ahead of print.
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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.
Flora Scheffenbichler, MD principal investigator
Department of Anesthesiology and Intensive Care Medicine, University of Ulm, Ulm, Germany.
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, Residual and Postoperative Complications, run by University Hospital Ulm at 1 site in Germany.
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 5 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: status not confirmed, as of the sponsor's last update on 24 Sep 2024. 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 Germany. 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?
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?
Precision of TOF (train of four) measurements (time frame: intraoperatively). 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 NCT06062290, which also lists 3 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 24 Sep 2024.