Status:
NOT_YET_RECRUITING
Comparison of Emergence Delirium: Remimazolam vs Sevoflurane Anesthesia
Lead Sponsor:
Second Affiliated Hospital of Wenzhou Medical University
Conditions:
Emergence Delirium
Eligibility:
All Genders
3-6 years
Phase:
PHASE4
Brief Summary
Emergence delirium can lead to a range of clinical problems and is even associated with short-term behavioral changes in children. Pediatric ear, nose, and throat (ENT) surgery is one of the most comm...
Detailed Description
children aged 3-6 years old were randomly and equally allocated into two groups: Group R remimazolam, Group S with sevoflurane, respectively.
Eligibility Criteria
Inclusion
- Age 3-6 years;
- American Society of Anaesthesiologist (ASA) I or II;
- Booked for Tonsillectomy and Adenoidectomy;
- BMI for age between the 25th and 85th percentiles according to the 2000 Centers for Disease Control and Prevention (CDC) growth charts.
Exclusion
- Children (ASA III- IV) who had abnormal liver and kidney function, cardiovascular, endocrine dysfunction, or any other organ dysfunction;
- Allergy or hypersensitive reaction to remimazolam;
- mental disorder
- Recently respiratory infection;
- Other reasons that researchers hold it is not appropriate to participate in this trial: under specialized care or lived in social welfare institutions, or any other factors that could affect their ability to participate in the study.
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2025
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06214117
Start Date
February 1 2024
End Date
March 1 2025
Last Update
January 19 2024
Active Locations (1)
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1
The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China