Status:
COMPLETED
Intranasal Remimazolam for Premedication in Pediatric Patient
Lead Sponsor:
Second Affiliated Hospital of Wenzhou Medical University
Conditions:
Sedative; Anxiety Disorder
Eligibility:
All Genders
2-5 years
Phase:
PHASE4
Brief Summary
Anesthetic inhalation induction could be one of the most stressful experiences for children during the perioperative period, with almost 50% of them showing anxiety. It is an essential challenge for p...
Detailed Description
children aged 2-5 years old were randomly allocated into three equal groups based on the premedication routes: Group R with intranasal remimazolam, Group D with intranasal dexmedetomidine and Group P ...
Eligibility Criteria
Inclusion
- with American Society of Anesthesiologists (ASA) physical status I or II；
- aged 2-5 years；
- children with weight for age within the normal range
- were scheduled surgery with general anesthesia
Exclusion
- Children who had gastrointestinal,Cardiovascular or endocrine dysfunction;
- contraindication to preoperative sedation or had a known allergy or hypersensitive reaction to either dexmedetomidine or remimazolam;
- with any nasal pathology,organ dysfunction;
- recently respiratory infection, mental disorder;
- other reasons that researchers hold it is not appropriate to participate in this trial.-
Key Trial Info
Start Date :
February 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2022
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04720963
Start Date
February 7 2021
End Date
February 28 2022
Last Update
September 8 2023
Active Locations (1)
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1
The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China