An interventional study of remimazolam group and dexmedetomidine group in Remimazolam, Dexmedetomidine and Esketamine, sponsored by Maternal and Child Health Hospital of Hubei Province. Recruiting at 1 site in China. Open to participants aged 2 Years to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-10.
Sponsored by Maternal and Child Health Hospital of Hubei Province · Not applicable, Interventional, and Prevention
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.
Participants will be randomly allocated to three groups: remimazolam group(Group A), dexmedetomidine group(Group B), esketamine group(Group C). Before entering the operating room, an intravenous access is established. Under the accompaniment of a parent, one of the three drugs is administered intravenously.
Maternal and Child Health Hospital of Hubei Province is the lead sponsor of 13 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Remimazolam is administered intravenously at a dose of 0.3 mg/kg
Drug: remimazolam group
dexmedetomidine is administered intravenously at a dose of 1 μg/kg
Drug: dexmedetomidine group
esketamine is administered intravenously at a dose of 0.5 mg/kg
Drug: esketamine group
remimazolam is administered intravenously at a dose of 0.3 mg/kg
Also known as: remimazolam
dexmedetomidine is administered intravenously at a dose of 1 μg/kg
Also known as: dexmedetomidine
esketamine is administered intravenously at a dose of 0.5 mg/kg
Also known as: esketamine
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.
Time frame: 0, 3, 5, 10 minutes after the drug injection
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.
Time frame: 0, 3, 5, 10 minutes after the drug injection
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
Time frame: 0, 3, 5, 10 minute after the drug injection
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
Time frame: 0, 3, 5, 10 minutes after the drug injection
incidence of adverse reactions
Time frame: during intravenous bolus administration of sedative drugs and anesthesia induction
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.
Time frame: 0, 5, 10, 20 minutes after the patient awake
Heart rate
Time frame: 0, 3, 5, and 10 minutes after the drug injection
blood pressure
systolic pressure and diastolic pressure
Time frame: 0,3,5,10 minute after drug injectuion
respiratory rate
Time frame: 0,3,5,10 minute after drug injectuion
pulse oximetry saturation
Time frame: 0,3,5,10 minute after drug injectuion
Plan to share: Yes — I plan to share IPD after the end of this study, including the study protocol, informed consent form and clinical study report.
Supporting information: Study protocol, Icf, Csr
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Maternal and Child Health Hospital of Hubei Province