Status:
COMPLETED
The ED95 of Single Intravenous Bolus Remimazolam Besylate in Pediatric Patients During General Anesthesia Induction
Lead Sponsor:
Second Affiliated Hospital of Wenzhou Medical University
Conditions:
Pediatric
ED95
Eligibility:
All Genders
1-12 years
Phase:
PHASE4
Brief Summary
Due to the incomplete development of systems and low pain thresholds in the pediatric population, good general anesthesia is required during the perioperative period to ensure the smooth progress of t...
Detailed Description
This experiment was divided into three groups based on the age of the children, namely 1-3 years old, 4-6 years old, 7-12 years old, with an initial dose of 0.2mg/kg. The time of consciousness loss in...
Eligibility Criteria
Inclusion
- with American Society of Anesthesiologists (ASA) physical status I or II；
- aged 1-12 years；
- children with weight for age within the normal range；
- were scheduled general anesthesia surgery
Exclusion
- Children who had gastrointestinal,Cardiovascular or endocrine dysfunction;
- contraindication to preoperative sedation or had a known allergy or hypersensitive reaction to remimazolam;
- recently respiratory infection, mental disorder;
- other reasons that researchers hold it is not appropriate to participate in this trial.
Key Trial Info
Start Date :
October 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 27 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06061159
Start Date
October 6 2023
End Date
February 27 2024
Last Update
February 7 2025
Active Locations (1)
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1
The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China