Application of Remimazolam, Dexmedetomidine, and Esketamine in Pediatric Preoperative Sedation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-5
SponsorMaternal and Child Health Hospital of Hubei Province

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • remimazolam group

    Drug

    remimazolam is administered intravenously at a dose of 0.3 mg/kg

  • dexmedetomidine group

    Drug

    dexmedetomidine is administered intravenously at a dose of 1 μg/kg

  • esketamine group

    Drug

    esketamine is administered intravenously at a dose of 0.5 mg/kg

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: Remimazolam group: Remimazolam is administered intravenously at a dose of 0.3 mg/kgExperimental treatment 1 intervention
Group B: dexmedetomidine group: dexmedetomidine is administered intravenously at a dose of 1 μg/kgActive comparator 1 intervention
Group C: esketamine group: esketamine is administered intravenously at a dose of 0.5 mg/kgActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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

Secondary outcomes

1

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
2

incidence of adverse reactions

Time frame
during intravenous bolus administration of sedative drugs and anesthesia induction
3

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
4

Heart rate

Time frame
0, 3, 5, and 10 minutes after the drug injection

Other outcomes

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