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

NCT07050212 | Recruiting DMC

• 1 other identifier: MCHH_013
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Remimazolam; Dexmedetomidine; Esketamine

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (7)

• Mask Acceptance Score (MAS)

  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)

  0, 5, 10, 20 minutes after the patient awake

• Heart rate

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

• blood pressure

  0,3,5,10 minute after drug injectuion

Study Arms (3)

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

Drug: remimazolam group

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

Drug: dexmedetomidine group

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

Drug: esketamine group

Interventions

remimazolam group DRUG

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

Also known as: remimazolam

Remimazolam group: 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

Also known as: dexmedetomidine

dexmedetomidine group: 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

Also known as: esketamine

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

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Maternal and Child Health Hospital of Hubei Province: lead

Study Sites (1)

Maternal and Child Health Hospital of Hubei Province

Wuhan, Hubei, 430000, China

RECRUITING

MeSH Terms

Interventions

remimazolam; Dexmedetomidine; Esketamine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Na Li NaLi, MD

  Maternal and Child Health Hospital of Hubei Province

  PRINCIPAL INVESTIGATOR

Central Study Contacts

NaLi, MD

CONTACT

+862763490107; lina@hbfy.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief Physician

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: July 3, 2025
• Study Start: April 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: July 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: after the end of this study
• Access Criteria: all

Locations

CN (1)