Preventive Effect of Remimazolam on Emergence Agitation in Children

JRCT ID: jRCTs051240010

Registered date:16/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Emergence delirium
• Date of first enrollment: 16/04/2024
• Target sample size: 60
• Study type: Interventional
• Intervention(s): Remimazolam 0.15mg/kg at the end of the surgery

Outcome(s)

• Primary Outcome: Maximum Pediatric Anesthesia Emergence Delirium (PAED) score
• Secondary Outcome: The awakening agitation incidence rate, time to awakening (time from anesthesia end to eye opening), postoperative pain (FLACC scale), parental satisfaction (NRS), and the proportion of adverse events.

Key inclusion & exclusion criteria

• Age minimum: >= 2age old
• Age maximum: <= 7age old
• Gender: Both

Include criteria

- 2-7 yo
- Patients undergoing surgery under general anesthesia
- Written consent obtained from the legal guardians or minors' caregivers regarding participation in the study

Exclude criteria

- Patients eligible for this study from the second occurrence during the study period
- Patients with neurological disorders, cardiovascular diseases, or respiratory disorders
- Patients undergoing neurosurgery, cardiac surgery, or transplantation surgery
- Patients scheduled for thoracotomy or laparotomy
- Respiratory tract infection within the past month
- Developmental disorders
- Preoperative sedative administration
- Patients for whom remimazolam administration is not recommended (remimazolam hypersensitivity, glaucoma, severe myasthenia gravis)
- Other patients deemed unsuitable for participation in this study by the principal investigator or research collaborator

Related Information

• Primary Sponsor: Kimura Satoshi