Status:
RECRUITING
Determination of ED50 and ED95 With Clinical Efficacy of Intranasal Dexmedetomidine Combined With Esketamine for Preoperative Sedation in Pediatric General Anesthesia
Lead Sponsor:
Second Affiliated Hospital of Wenzhou Medical University
Conditions:
Preoperative Anxiety
Preoperative Sedation
Eligibility:
All Genders
12-72 years
Phase:
PHASE4
Brief Summary
For pediatric patients undergoing general anesthesia, poor anesthesia induction compliance often has adverse effects on individual behavior in the early postoperative period. Dexmedetomidine can reduc...
Detailed Description
Children scheduled for general anesthesia were randomly divided into two groups based on age: Group T consisted of toddlers aged 1 - 3 years old, and Group P consisted of preschool children aged 3 - 6...
Eligibility Criteria
Inclusion Criteria:
- ASA physical status classification Grade I or II;
- Age 1-6 years old;
- Children who need to undergo general anesthesia for elective surgery;
- Weight within the normal range;
- Signed informed consent form. -
Exclusion Criteria:
- The child's guardian or the child themselves refuses to participate in the study;
- Patients with contraindications for sedation/anesthesia or a history of abnormal recovery from sedation/anesthesia;
- Individuals known to be allergic to the study drugs, opioid drugs, or rescue medications;
- Individuals with a history of heart, brain, liver, kidney, or metabolic diseases;
- Individuals with an upper respiratory tract infection within the past two weeks;
- Individuals with other diseases that may cause harm to the subject. -
Key Trial Info
Start Date :
March 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06853431
Start Date
March 1 2025
End Date
November 30 2025
Last Update
December 2 2025
Active Locations (2)
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1
The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
2
The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000