Remimazolam, dexmedetomidine, or esketamine to calm young children before surgery

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

This trial will test which of three drugs—remimazolam, dexmedetomidine, or esketamine—best calms children aged 2–5 before adenotonsillectomy and reduces postoperative agitation.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 2 Years to 5 Years
• Sex: All
• Sponsor: Maternal and Child Health Hospital of Hubei Province (other)
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT07050212 on ClinicalTrials.gov

What this trial studies

Children aged 2–5 years with ASA physical status I who are scheduled for adenotonsillectomy will be randomly assigned to one of three intravenous preoperative sedative groups: remimazolam, dexmedetomidine, or esketamine, given before entering the operating room with a parent present. Investigators will monitor sedation depth, vital signs, and emergence agitation after surgery to compare safety and effectiveness across groups. The protocol focuses on immediate preoperative calming and the impact of each drug on postoperative agitation. All procedures are conducted at a single center, the Maternal and Child Health Hospital of Hubei Province.

Who should consider this trial

Good fit: Ideal candidates are children aged 2–5 years with ASA Class I who are scheduled for adenotonsillectomy and do not have significant respiratory, airway, cardiac, or psychiatric conditions.

Not a fit: Children with abnormal lung or respiratory function, airway obstruction or deformity, significant cardiac disease or bradycardia, a history of mental illness, or those outside the 2–5 year age range are unlikely to benefit and are excluded.

Why it matters

Potential benefit: If successful, the study could identify a safer, more effective, and more personalized preoperative sedative for young children, reducing anxiety and postoperative agitation.

How similar studies have performed: Dexmedetomidine has documented pediatric use for preoperative sedation and reducing agitation, while remimazolam and esketamine have more limited pediatric comparative data, so this head-to-head comparison is partly novel.

Eligibility criteria

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

Where this trial is running

Wuhan, Hubei

• Maternal and Child Health Hospital of Hubei Province — Wuhan, Hubei, China (RECRUITING)

Study contacts

• Principal investigator: Na Li NaLi, MD — Maternal and Child Health Hospital of Hubei Province
• Study coordinator: NaLi, MD

Conditions: Remimazolam, Dexmedetomidine, Esketamine