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

Maternal and Child Health Hospital of Hubei Province

Status: Enrolling

Conditions: Remimazolam; Esketamine; Dexmedetomidine

Treatments: Drug: esketamine group; Drug: remimazolam group; Drug: dexmedetomidine group

Study type: Interventional

Funder types: Other

Identifiers

NCT07050212

MCHH_013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 2 to 5 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

150 participants in 3 patient groups

Remimazolam group: Remimazolam is administered intravenously at a dose of 0.3 mg/kg

Experimental group

Description:

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

Treatment:

Drug: remimazolam group

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

Active Comparator group

Description:

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

Treatment:

Drug: dexmedetomidine group

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

Active Comparator group

Description:

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

Treatment:

Drug: esketamine group