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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remimazolam group: Remimazolam is administered intravenously at a dose of 0.3 mg/kg | Experimental | Remimazolam is administered intravenously at a dose of 0.3 mg/kg |
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| dexmedetomidine group: dexmedetomidine is administered intravenously at a dose of 1 μg/kg | Active Comparator | dexmedetomidine is administered intravenously at a dose of 1 μg/kg |
|
| esketamine group: esketamine is administered intravenously at a dose of 0.5 mg/kg | Active Comparator | esketamine is administered intravenously at a dose of 0.5 mg/kg |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| remimazolam group | Drug | remimazolam is administered intravenously at a dose of 0.3 mg/kg |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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 | 0, 3, 5, 10 minute after the drug injection |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| NaLi, MD | Contact | +862763490107 | lina@hbfy.com |
| Name | Affiliation | Role |
|---|---|---|
| Na Li NaLi, MD | Maternal and Child Health Hospital of Hubei Province | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maternal and Child Health Hospital of Hubei Province | Recruiting | Wuhan | Hubei | 430000 | China |
I plan to share IPD after the end of this study, including the study protocol, informed consent form and clinical study report.
after the end of this study
all
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| ID | Term |
|---|---|
| C522201 | remimazolam |
| D020927 | Dexmedetomidine |
| C000629870 | Esketamine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| dexmedetomidine group | Drug | dexmedetomidine is administered intravenously at a dose of 1 μg/kg |
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| esketamine group | Drug | esketamine is administered intravenously at a dose of 0.5 mg/kg |
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| 0, 3, 5, 10 minutes after the drug injection |
| incidence of adverse reactions | 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. | 0, 5, 10, 20 minutes after the patient awake |
| Heart rate | 0, 3, 5, and 10 minutes after the drug injection |
| blood pressure | systolic pressure and diastolic pressure | 0,3,5,10 minute after drug injectuion |
| respiratory rate | 0,3,5,10 minute after drug injectuion |
| pulse oximetry saturation | 0,3,5,10 minute after drug injectuion |