Measuring of the Duration of Action of Different Doses of Rocuronium-induced Neuromuscular Block in Infants During Surgical Treatment of Craniosynostosis
NCT ID: NCT07080528
Last Updated: 2025-08-05
Study Results
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Basic Information
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ENROLLING_BY_INVITATION
PHASE4
20 participants
INTERVENTIONAL
2024-07-06
2025-08-30
Brief Summary
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Unfortunately, quantitative monitoring of neuromuscular block is not routinely used in everyday practice - and this is particularly true in the infant and child population. In adults, the relative absence of easy-to-use and reliable monitors has led to the neglect of neuromuscular monitoring. One of the monitoring techniques suitable for this purpose is electromyography. This EMG-based instrument (TetraGraph ® ) measures the action potential of the musculus adductor pollicis or the musculus abductor digiti minimi muscles.
Clinical trials have shown that for quantitative monitoring of the effect of muscle relaxants, extubation is safe if the TOF ratio is 0.9. Some studies have shown that TOF ratio of 0.95 is necessary to reduce the risk of postoperative respiratory complications.
In this study, investigators will use an EMG-based neuromuscular monitor, the TetraGraph ®, and an electrode specially designed for the infant and child population to measure the muscle relaxant (rocuronium) effect of infants undergoing decompressive surgery for craniosynostosis, from the time of induction until the TOF ratio of 0.9 is reached, using inhaled anaesthetic or intravenous agent to maintain anaesthesia.
In adult population it has been clearly demonstrated that inhaled anaesthetics potentiate the effect of muscle relaxants during maintenance anaesthesia, whereas this effect is moderate or negligible when intravenous maintenance agents are used. There is limited literature on the efficacy of rocuronium in the infant population when anaesthesia is maintained with sevoflurane or propofol. The aim of present study is to improve postoperative patient safety in the infant population.
Infants undergoing anaesthesia for elective craniosynostosis surgery are included in the study. The surgical preparation, anaesthesia of the patients, will be carried out in all aspects according to the daily routine, i.e.: All infants will receive 0.1 mg/kg midazolam i.v. for pre-medication. In the operating theatre, a peripheral vein is provided. Precordial ECG, pulse oximetry, blood pressure measurement, end-expiratory CO 2 , end-expiratory oxygen measurement will be performed during the surgery.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Effect of inhaled anaesthetics on muscle relaxants
Duration of action of rocuronium bromide under anaesthesia maintained with Sevoflurane
Sevofluorane
Investigation of the effect of Sevoflurane on muscle relaxation
Effect of intravenous anaesthetics on muscle relaxants
Duration of action of rocuronium bromide under anaesthesia maintained with Propofol
Propofol
Investigation of the effect of Propofol on muscle relaxation
Interventions
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Sevofluorane
Investigation of the effect of Sevoflurane on muscle relaxation
Propofol
Investigation of the effect of Propofol on muscle relaxation
Eligibility Criteria
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Inclusion Criteria
* Age: 3-12 months;
Exclusion Criteria
* Lack of parental consent
* Known allergy to any of the products used
3 Months
12 Months
ALL
No
Sponsors
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Tamas Vegh, MD
OTHER
Responsible Party
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Tamas Vegh, MD
MD PhD assistant professor, Head Division of General, Transplantation, Vascular and Thoracic Anesthesia
Principal Investigators
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Béla Fülesdi, MD PhD Full Professor DSc
Role: PRINCIPAL_INVESTIGATOR
University of Debrecen, Faculty of Medicine, Department of Anaesthesiology and Intensive Care
Locations
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University of Debrecen, Department of Anesthesiology and Intensive Care
Debrecen, Hajdú-Bihar, Hungary
Countries
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References
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Fuchs-Buder T, Tassonyi E. Intubating conditions and time course of rocuronium-induced neuromuscular block in children. Br J Anaesth. 1996 Sep;77(3):335-8. doi: 10.1093/bja/77.3.335.
Blobner M, Hunter JM, Meistelman C, Hoeft A, Hollmann MW, Kirmeier E, Lewald H, Ulm K. Use of a train-of-four ratio of 0.95 versus 0.9 for tracheal extubation: an exploratory analysis of POPULAR data. Br J Anaesth. 2020 Jan;124(1):63-72. doi: 10.1016/j.bja.2019.08.023. Epub 2019 Oct 10.
Fuchs-Buder T, Brull SJ, Fagerlund MJ, Renew JR, Cammu G, Murphy GS, Warle M, Vested M, Fulesdi B, Nemes R, Columb MO, Damian D, Davis PJ, Iwasaki H, Eriksson LI. Good clinical research practice (GCRP) in pharmacodynamic studies of neuromuscular blocking agents III: The 2023 Geneva revision. Acta Anaesthesiol Scand. 2023 Sep;67(8):994-1017. doi: 10.1111/aas.14279. Epub 2023 Jun 22.
Nemes R, Lengyel S, Nagy G, Hampton DR, Gray M, Renew JR, Tassonyi E, Fulesdi B, Brull SJ. Ipsilateral and Simultaneous Comparison of Responses from Acceleromyography- and Electromyography-based Neuromuscular Monitors. Anesthesiology. 2021 Oct 1;135(4):597-611. doi: 10.1097/ALN.0000000000003896.
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.
Fuchs-Buder T, Romero CS, Lewald H, Lamperti M, Afshari A, Hristovska AM, Schmartz D, Hinkelbein J, Longrois D, Popp M, de Boer HD, Sorbello M, Jankovic R, Kranke P. Peri-operative management of neuromuscular blockade: A guideline from the European Society of Anaesthesiology and Intensive Care. Eur J Anaesthesiol. 2023 Feb 1;40(2):82-94. doi: 10.1097/EJA.0000000000001769. Epub 2022 Nov 15.
Zarour S, Constantini S, Roth J, Friedman S, Kirgner I, Cohen B, Ekstein M. Postoperative coagulopathy among otherwise healthy pediatric patients undergoing open craniosynostosis repair: a retrospective study. Eur J Pediatr. 2023 Mar;182(3):1341-1349. doi: 10.1007/s00431-023-04805-8. Epub 2023 Jan 14.
Study Documents
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Document Type: Study Protocol
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Other Identifiers
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2024-515545-41-00
Identifier Type: CTIS
Identifier Source: secondary_id
AITT 2023/8
Identifier Type: -
Identifier Source: org_study_id
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