Effects on Respiratory Compliance with Sugammadex in Children on Ventilation

JRCT ID: jRCTs041220060

Registered date:30/08/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Persons undergoing surgery under general anesthesia
• Date of first enrollment: 22/09/2022
• Target sample size: 55
• Study type: Interventional
• Intervention(s): In pediatric patients undergoing general anesthesia with tracheal intubation, the EIT System Enlight 2100 is worn to observe respiratory compliance during sugammadex administration.

Outcome(s)

• Primary Outcome: Changes in respiratory compliance before and after sugammadex administration

Secondary Outcome

Changes in air content distribution before and after sugammadex administration
Correlation of changes in respiratory compliance with age, weight, and BMI
Presence or absence of adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 2age old
• Age maximum: <= 12age old
• Gender: Both

Include criteria

1. children between 2 and 12 years of age
2. who will undergo scheduled surgery under general anesthesia
3. who are scheduled to be intubated with muscle relaxation
4. who will undergo surgery in the supine position
5. who have obtained consent for participation in this study by signing a consent form by a surrogate

Exclude criteria

1. who are allergic to rocuronium or sugammadex
2. who have respiratory complications such as asthma or active upper airway inflammation as a preoperative complication
3. Patients with skin disease in the area of the EIT
4. Persons with a chest measurement of less than 50 cm
5. Patients with upper abdominal or thoracic surgery that precludes thoracic EIT.
6. who cannot wear an EIT due to thoracic deformity
7. Patients with congenital heart disease requiring treatment
8. patients with neuromuscular diseases 9. patients with liver or kidney dysfunction
9. who have hepatic or renal dysfunction
10. other persons whom the principal investigator or subinvestigator determines are not appropriate to be included in this study

Related Information

• Primary Sponsor: Yagihara Masahiro