About this trial
By comparing the application effects of three drugs in pediatric preoperative sedation, this study explores the optimal medication regimen, aiming to provide safer, more effective, and more personalized medication options for pediatric preoperative sedation. Additionally, this research will also focus on the impact of these three drugs on postoperative agitation in children, offering valuable references for the overall management of pediatric surgical anesthesia.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Children aged 2 to 5 years old
the American Society of Anesthesiologists (ASA) physical status of Class I
scheduled for adenotonsillectomy under general anesthesia, will be included.
Disqualifiers
Abnormal lung function and respiratory system function
airway obstruction or deformity, history of mental illness
electrocardiogram indicating bradycardia
history of cardiac disease
Trial design
Parallel
Treatments tested in this trial
remimazolam group
Drugremimazolam is administered intravenously at a dose of 0.3 mg/kg
dexmedetomidine group
Drugdexmedetomidine is administered intravenously at a dose of 1 μg/kg
esketamine group
Drugesketamine is administered intravenously at a dose of 0.5 mg/kg
Treatment groups
Trial outcomes
Primary outcomes
Sedation success rate
1 points represents the child being restless and irritable; 2 points represents that the child is quiet and cooperative; 3 points represents that the child is drowsy and able to obey instructions; A score of 4 indicates that the child is in a shallow sleep state and can be quickly awakened; 5 points represent the child falling asleep and having a slow response to calls; 6 points represent the child's deep sleep state and no response to calls. If the Ramasay score greater than 2 points, it is considered a successful sedation.
Onset time of sedation
The time from the end of drug injection until the Ramsay score is greater than 2 points. If the Ramasay score greater than 2 points, it is considered a successful sedation. 1 points of ramasay scorere presents the child being restless and irritable; 2 points represents that the child is quiet and cooperative; 3 points represents that the child is drowsy and able to obey instructions; A score of 4 indicates that the child is in a shallow sleep state and can be quickly awakened; 5 points represent the child falling asleep and having a slow response to calls; 6 points represent the child's deep sleep state and no response to calls.
Parent-Child Separation Anxiety Score (PASA Score)
if the PASA score is greater than 2, it is considered a positive reaction to separation anxiety. 1 point represents that the child is easily separated from their parents;A score of 2 indicates that the child has crying sounds, easily comforted, and does not rely on their parents;A score of 3 indicates that the child is crying and cannot be comforted, but does not rely on their parents;4 points represent the child crying and relying on their parents
Secondary outcomes
Mask Acceptance Score (MAS)
The MAS scale is used to evaluate the acceptance of respiratory masks in pediatric patients. Less than 2 points indicate satisfactory acceptance. 1 point represents that the child is fearless and easily accepts face masks; 2 points represent that the child is mildly fear of the face mask and easily be comfort; 3 points represent that the child is moderatly fear of the face mask and cannot be comforted; 4 points represent that the child is very afraid of the face mask and crying
incidence of adverse reactions
restlessness rating scale for awakening period(PAED)
When the PAED score is greater than 2 points, the child is identified as agitated during the recovery period; if the PAED score is greater than 10 points, the child is identified as delirium in the awakening period.
Heart rate
Sponsors and contacts
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