Actively Recruiting
A Comparative Study of Remimazolam, Dexmedetomidine, and Esketamine for Sedation Before Surgery in Children Aged 2 to 5 Years
Led by Maternal and Child Health Hospital of Hubei Province · Updated on 2025-07-10
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare the effects of three drugs used for sedation before surgery in children aged 2 to 5 years. It focuses on finding the best medication plan to provide safer, more effective, and personalized sedation options for young patients. The study also examines how these drugs affect agitation after surgery, helping improve overall management of pediatric anesthesia. Participants will be randomly assigned to one of three groups receiving different drugs: remimazolam at 0.3 mg/kg, dexmedetomidine at 1 g/kg, or esketamine at 0.5 mg/kg. Each drug is given through an intravenous line before the child enters the operating room, with a parent present during administration. This study uses a triple-blind design to assess each drug's effects. During the study, researchers will monitor sedation success rate, time to sedation onset, and anxiety levels related to parent-child separation at multiple time points after drug injection. Additional assessments include mask acceptance, adverse reactions during sedation and anesthesia induction, restlessness during awakening, and vital signs such as heart rate, blood pressure, respiratory rate, and oxygen levels. The total participation covers the period before surgery and immediate recovery, providing detailed data on sedation and safety.
CONDITIONS
Brief Title
Application of Remimazolam, Dexmedetomidine, and Esketamine in Pediatric Preoperative Sedation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 2 to 5 years old
- American Society of Anesthesiologists (ASA) physical status Class I
- Scheduled for adenotonsillectomy under general anesthesia
You will not qualify if you...
- Abnormal lung or respiratory system function
- Airway obstruction or deformity
- History of mental illness
- Electrocardiogram showing bradycardia
- History of cardiac disease
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 - Single session on surgery day
Participants receive one of three intravenous sedative drugs before surgery under parental accompaniment.
1 visit (in-person)
Duration - Approximately 20 minutes after drug injection
Participants are monitored for sedation effects and any adverse reactions during and shortly after drug administration and anesthesia induction.
Continuous monitoring during treatment visit
Trial Site Locations
Total: 1 location
1
Maternal and Child Health Hospital of Hubei Province
Wuhan, Hubei, China, 430000
Actively Recruiting
Research Team
N
NaLi, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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