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

Not Applicable

Recruiting

• Conditions: Remimazolam; Dexmedetomidine; Esketamine
• Interventions: Drug: remimazolam group; Drug: dexmedetomidine group; Drug: esketamine group

• Registration Number: NCT07050212
• Lead Sponsor: Maternal and Child Health Hospital of Hubei Province

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.

Study Timeline

• Status Verified: 2025-03
• Study Start: 2025-04-01
• Study First Submitted: 2025-06-12
• Study First Submitted QC: 2025-06-24
• Study First Posted: 2025-07-03
• Last Update Submitted: 2025-07-04
• Last Update Posted: 2025-07-10
• Primary Completion: 2026-03-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remimazolam group: Remimazolam is administered intravenously at a dose of 0.3 mg/kg	remimazolam group	Remimazolam is administered intravenously at a dose of 0.3 mg/kg
dexmedetomidine group: dexmedetomidine is administered intravenously at a dose of 1 μg/kg	dexmedetomidine group	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	esketamine group	esketamine is administered intravenously at a dose of 0.5 mg/kg

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
incidence of adverse reactions	during intravenous bolus administration of sedative drugs and anesthesia induction
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
blood pressure	0,3,5,10 minute after drug injectuion	systolic pressure and diastolic pressure
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.
respiratory rate	0,3,5,10 minute after drug injectuion
Heart rate	0, 3, 5, and 10 minutes after the drug injection
pulse oximetry saturation	0,3,5,10 minute after drug injectuion

Trial Locations

Locations (1)

Maternal and Child Health Hospital of Hubei Province; 🇨🇳 Wuhan, Hubei, China