Remimazolam, Dexmedetomidine, Esketamine
Conditions
Brief summary
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.
Detailed description
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.
Interventions
remimazolam is administered intravenously at a dose of 0.3 mg/kg
DRUGdexmedetomidine group
dexmedetomidine is administered intravenously at a dose of 1 μg/kg
DRUGesketamine group
esketamine is administered intravenously at a dose of 0.5 mg/kg
Sponsors
Maternal and Child Health Hospital of Hubei Province
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 5 Years
Healthy volunteers
Yes
Inclusion criteria
1. Children aged 2 to 5 years old 2. the American Society of Anesthesiologists (ASA) physical status of Class I 3. scheduled for adenotonsillectomy under general anesthesia, will be included.
Exclusion criteria
1. Abnormal lung function and respiratory system function 2. airway obstruction or deformity, history of mental illness 3. electrocardiogram indicating bradycardia 4. history of cardiac disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sedation success rate | 0, 3, 5, 10 minutes after the drug injection | 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 | 0, 3, 5, 10 minutes after the drug injection | 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) | 0, 3, 5, 10 minute after the drug injection | 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
| Measure | Time frame | Description |
|---|---|---|
| Heart rate | 0, 3, 5, and 10 minutes after the drug injection | — |
| blood pressure | 0,3,5,10 minute after drug injectuion | systolic pressure and diastolic pressure |
| Mask Acceptance Score (MAS) | 0, 3, 5, 10 minutes after the drug injection | 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 |
| pulse oximetry saturation | 0,3,5,10 minute after drug injectuion | — |
| respiratory rate | 0,3,5,10 minute after drug injectuion | — |
| incidence of adverse reactions | during intravenous bolus administration of sedative drugs and anesthesia induction | — |
| restlessness rating scale for awakening period(PAED) | 0, 5, 10, 20 minutes after the patient awake | 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. |
Countries
China
Contacts
Primary ContactNaLi, MD
Outcome results
None listed