Comparing two methods for monitoring muscle relaxation in young children during surgery
Objective Neuromuscular Monitoring in Children (6 Months - 2 Years) With Electromyography and Acceleromyography: A Randomized Study
NA · Rigshospitalet, Denmark · NCT06409260
This study is testing whether a new method for monitoring muscle relaxation during surgery can help young children recover faster than the traditional method.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 6 Months to 2 Years |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark (other) |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT06409260 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of Acceleromyography (AMG) and Electromyography (EMG) in monitoring neuromuscular blockade in children aged 6 months to 2 years undergoing elective surgery with general anesthesia. The monitoring will be performed bilaterally on either the ulnar or tibial nerve. The hypothesis is that AMG will demonstrate a faster recovery time to a Train Of Four (TOF) ratio of 90% compared to EMG, addressing challenges in neuromuscular monitoring in smaller patients. The study seeks to improve safety and efficacy in pediatric anesthesia.
Who should consider this trial
Good fit: Ideal candidates are children aged 6 months to 2 years scheduled for elective surgery requiring general anesthesia and intubation with rocuronium.
Not a fit: Patients with known allergies to rocuronium, neuromuscular diseases, or those requiring rapid sequence induction may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring techniques that enhance recovery times and safety for young children undergoing surgery.
How similar studies have performed: While there have been studies on neuromuscular monitoring in adults, this specific comparison in young children is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients 6 months - 2 years of age * Scheduled for elective surgery under general anaesthesia with intubation and use of rocuronium * American Society of Anesthesiologists (ASA) physical status classification I to III Exclusion Criteria: * Known allergy to rocuronium * Neuromuscular disease that may interfere with neuromuscular data * Indication for rapid sequence induction * Prone position
Where this trial is running
Copenhagen
- Rigshospitalet — Copenhagen, Denmark (RECRUITING)
Study contacts
- Study coordinator: Matias Vested
- Email: matias.vested@regionh.dk
- Phone: +4535455747
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Neuromuscular Blockade