Skip to main content
Clinical Trials/NCT07080528
NCT07080528
Enrolling By Invitation
Phase 4

Measuring of the Duration of Action of Different Doses of Rocuronium-induced Neuromuscular Block in Infants During Surgical Treatment of Craniosynostosis - a Prospective, Case-controlled Study

Tamas Vegh, MD1 site in 1 country20 target enrollmentStarted: July 6, 2024Last updated:

Overview

Phase
Phase 4
Status
Enrolling By Invitation
Sponsor
Tamas Vegh, MD
Enrollment
20
Locations
1
Primary Endpoint
Time till TOF ratio of 0.9

Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
3 Months to 12 Months (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

Effect of inhaled anaesthetics on muscle relaxants

Experimental

Duration of action of rocuronium bromide under anaesthesia maintained with Sevoflurane

Intervention: Sevofluorane (Drug)

Effect of intravenous anaesthetics on muscle relaxants

Experimental

Duration of action of rocuronium bromide under anaesthesia maintained with Propofol

Intervention: Propofol (Drug)

Outcomes

Primary Outcomes

Time till TOF ratio of 0.9

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

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

Secondary Outcomes

  • 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.)

Investigators

Sponsor
Tamas Vegh, MD
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Tamas Vegh, MD

MD PhD assistant professor, Head Division of General, Transplantation, Vascular and Thoracic Anesthesia

University of Debrecen

Study Sites (1)

Loading locations...

Similar Trials