Development of an early detection method for laryngospasm using surface electromyography: a prospective observational study

JRCT ID: jRCT1040240148

Registered date:17/12/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Diseases requiring surgery under general anesthesia
• Date of first enrollment: 17/12/2024
• Target sample size: 100
• Study type: Observational
• Intervention(s): none

Outcome(s)

• Primary Outcome: Relationship between the occurrence of laryngospasm and surface electromyographic changes

Secondary Outcome

Frequency of laryngospasm by severity and time of onset
Patient and anesthetic factors associated with the occurence of laryngospasm
Development of prediction models for laryngospasm

Key inclusion & exclusion criteria

• Age minimum: >= 1age old
• Age maximum: < 10age old
• Gender: Both

Include criteria

1) Male and female patients who are at least 1 year but less than 10 years old at the time of surgery
2) Patients who have written consent from a surrogate to participate in the study
3) Patients with an ASA-PS (American Society of Anesthesiologists physical status) of 1 or 2 (healthy or mild systemic disease).
4) Patients who are considered eligible for supraglottic airway management

Exclude criteria

1) Patients undergoing emergency surgery
2) Patients with neuromuscular diseases
3) Patients with cyanotic congenital heart disease
4) Patients with preoperative intubation or tracheostomy
5) Patients expected to have difficulty securing the airway with supraglottic airway devices or tracheal intubation
6) Patients deemed ineligible for the study by the investigators

Related Information

• Primary Sponsor: Nakanishi Toshiyuki
• Source(s) of Monetary Support: Japan Science and Technology Agency