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NCT Number: NCT07050212

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

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.

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Key information

Conditions

Remimazolam Dexmedetomidine Esketamine

Age range

2 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maternal and Child Health Hospital of Hubei Province

Wuhan, Hubei, 430000, China

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Abnormal lung function and respiratory system function
  • airway obstruction or deformity, history of mental illness
  • electrocardiogram indicating bradycardia
  • history of cardiac disease

Treatment and study plan

Remimazolam group

Drug

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

Other names: remimazolam

dexmedetomidine group

Drug

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

Other names: dexmedetomidine

Esketamine group

Drug

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

Other names: esketamine

Primary outcomes

  1. Sedation success rate

    Time frame: 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.

  2. Onset time of sedation

    Time frame: 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.

  3. Parent-Child Separation Anxiety Score (PASA Score)

    Time frame: 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 outcomes

  1. Mask Acceptance Score (MAS)

    Time frame: 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

  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)

    Time frame: 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.

  4. Heart rate

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

  5. blood pressure

    Time frame: 0,3,5,10 minute after drug injectuion

    systolic pressure and diastolic pressure

  6. respiratory rate

    Time frame: 0,3,5,10 minute after drug injectuion

  7. pulse oximetry saturation

    Time frame: 0,3,5,10 minute after drug injectuion

Study contacts

Contact information is provided by the study sponsor or research team.

NaLi, MD

CONTACT

[email protected]

+862763490107

Sponsors and collaborators

Lead sponsor

Maternal and Child Health Hospital of Hubei Province

Other

Registry information

Official study title

A Comparative Study of the Application of Remimazolam, Dexmedetomidine, and Esketamine in Pediatric Preoperative Sedation

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 3, 2025
Registry last updated
Jul 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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