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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| neonates | birth to <28 days |
| |
| infants | 28 days to ≤3 months |
| |
| toddlers | >3 months to ≤2 years |
| |
| children | >2 years to <5 years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electromyography (EMG) | Device | Measurement of the compound muscle action potential for the assessment of neuromuscular function |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | intraoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Tactile TOF-count measurement | Tactile measurement of TOF response (EMG and KMG) | intraoperatively |
| Postoperative pulmonary events | Including upper airway obstruction, hypoxemia, respiratory distress, aspiration, reintubation (Murphy et al.) |
Inclusion Criteria:
Exclusion Criteria:
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The ETCETERA study will be performed in children <5 years of age scheduled for elective, non-cardiac surgery requiring general anaesthesia and neuromuscular blockade.
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| Name | Affiliation | Role |
|---|---|---|
| Flora Scheffenbichler, MD | Department of Anesthesiology and Intensive Care Medicine, University of Ulm, Ulm, Germany. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Ulm | Ulm | Baden-Wurttemberg | 89073 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9689392 | Background | 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. | |
| 18635478 | Background | Murphy 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 11, 2023 | Jul 24, 2023 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D055191 | Delayed Emergence from Anesthesia |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004576 | Electromyography |
| ID | Term |
|---|---|
| D004568 | Electrodiagnosis |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D009213 | Myography |
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| Kinemyography (KMG) | Device | Measurement of the muscle velocity for the assessment of neuromuscular function |
|
| intraoperatively |
| on the day of surgery in the recovery room |
| Skin lesions, redness and pressure points on the forearms | Clinical safety outcome | on the day of surgery in the recovery room and at hospital discharge or on postoperative day 7, whichever occurs earlier |
| Pain associated with the EMG and KMG measurement | Assessment through child discomfort and pain scale (KUSS) (Bittner et al.) | on the day of surgery in the recovery room and at hospital discharge or on postoperative day 7, whichever occurs earlier |