Actively Recruiting
Determination of ED50 and ED95 and Clinical Effects of Intranasal Dexmedetomidine Combined With Esketamine for Preoperative Sedation in Pediatric General Anesthesia
Led by Second Affiliated Hospital of Wenzhou Medical University · Updated on 2025-12-02
80
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to explore the effective dose levels (ED50 and ED95) and clinical effects of combining intranasal dexmedetomidine and esketamine for preoperative sedation in children aged 1 to 6 years undergoing general anesthesia. The study focuses on improving sedation compliance to reduce adverse behavioral effects after surgery and provides a theoretical basis for using these drugs together for sedation in pediatric patients. Children are divided into two age groups: toddlers (1-3 years) and preschool children (3-6 years). Both groups receive an initial intranasal dose of dexmedetomidine (1 µg/kg) combined with esketamine (0.5 mg/kg). The dexmedetomidine dose is adjusted in increments of 0.25 µg/kg based on sedation success using a biased coin design. Sedation depth is assessed every 5 minutes with the Ramsay Sedation Scale, and sedation onset time is recorded. Intravenous cannulation and emotional state assessments occur 30 minutes after drug administration. Participants undergo continuous monitoring of vital signs including blood pressure, heart rate, respiratory rate, and oxygen saturation before and after drug administration. Sedation onset, surgical time, awakening time, and emergence delirium are recorded. The study also evaluates intravenous cannulation success and adverse effects up to 24 hours. The total observation includes perioperative and postoperative periods to assess sedation effectiveness and safety.
CONDITIONS
Brief Title
Determination of ED50 and ED95 With Clinical Efficacy of Intranasal Dexmedetomidine Combined With Esketamine for Preoperative Sedation in Pediatric General Anesthesia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 30 minutes
Participants receive intranasal administration of esketamine and dexmedetomidine for preoperative sedation. Sedation depth is assessed every 5 minutes, and vital signs are monitored for 30 minutes after drug administration. Intravenous cannulation is performed 30 minutes after drug administration with assessment of emotional state during the procedure.
1 visit (in-person)
Duration - Up to 24 hours
Participants are monitored for awakening time, postoperative agitation, and adverse effects for up to 24 hours after the procedure.
1 post-operative visit (in-person)
Trial Site Locations
Total: 2 locations
1
The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Not Yet Recruiting
2
The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Actively Recruiting
Research Team
H
Huacheng Liu
C
Chenrui Zhou
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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