Measuring of the Duration of Action of Different Doses of Rocuronium-induced Neuromuscular Block in Infants During Surgical Treatment of Craniosynostosis

NCT07080528 | Enrolling By Invitation Phase 4 DMC

• 2 other identifiers: AITT 2023/82024-515545-41-00
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The use of intravenous muscle relaxants during anaesthesia can significantly facilitate endotracheal intubation and reduce the chance of possible airway complications during intubation. Overall, muscle relaxants make anaesthesia safer. Quantitative measurement of neuromuscular block is essential when anaesthesiologists use muscle relaxants. It allows to avoid postoperative residual block complications such as upper airway obstruction, hypoxia, pharyngeal dysfunction, aspiration. 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.

Conditions

Neuromuscular Blocking Agents; Residual Neuromuscular Block; Neuromuscular Blockade Monitoring

Outcome Measures

Primary Outcomes (1)

• Time till TOF ratio of 0.9

  The primary end point will be to compare the time needed to reach TOFR 0.9 after a single, 0.6 mg/kg dose of rocuronium in anaesthesia maintained by propofol and sevoflurane

  From administration of rocuronium to achieve TOF ratio 0.9, during a surgical procedure due to craniosynostosis.

Secondary Outcomes (1)

• Time til TOF count 1, 2, 3, 4

  From the administration of rocuronium to achieve TOF count 1, 2, 3, 4, during a surgical procedure due to craniosynostosis.

Study Arms (2)

Effect of inhaled anaesthetics on muscle relaxants

EXPERIMENTAL

Duration of action of rocuronium bromide under anaesthesia maintained with Sevoflurane

Drug: Sevofluorane

Effect of intravenous anaesthetics on muscle relaxants

EXPERIMENTAL

Duration of action of rocuronium bromide under anaesthesia maintained with Propofol

Drug: Propofol

Interventions

Sevofluorane DRUG

Investigation of the effect of Sevoflurane on muscle relaxation

Effect of inhaled anaesthetics on muscle relaxants

Propofol DRUG

Investigation of the effect of Propofol on muscle relaxation

Effect of intravenous anaesthetics on muscle relaxants

Eligibility Criteria

• Age: 3 Months - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• infants whose parents have given informed written consent to participate in the studies;
• Age: 3-12 months;

You may not qualify if:

• diseases affecting neuromuscular function (myopathies, severe liver and kidney failure);
• Lack of parental consent
• Known allergy to any of the products used

Sponsors & Collaborators

• Tamas Vegh, MD: lead

Study Sites (1)

University of Debrecen, Department of Anesthesiology and Intensive Care

Debrecen, Hajdú-Bihar, 4032, Hungary

Location

Related Publications (7)

• 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.

  PMID: 8949805 BACKGROUND

• 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.

  PMID: 31607388 BACKGROUND

• 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.

  PMID: 37345870 BACKGROUND

• 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.

  PMID: 34329371 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.

  PMID: 18635478 BACKGROUND

• 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.

  PMID: 36377554 BACKGROUND

• 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.

  PMID: 36639535 BACKGROUND

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MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Interventions

Propofol

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Béla Fülesdi, MD PhD Full Professor DSc

  University of Debrecen, Faculty of Medicine, Department of Anaesthesiology and Intensive Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD PhD assistant professor, Head Division of General, Transplantation, Vascular and Thoracic Anesthesia

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 23, 2025
• Study Start: July 6, 2024
• Primary Completion: August 30, 2025
• Study Completion: August 30, 2025
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)