Remimazolam, dexmedetomidine, or esketamine to calm young children before surgery
Official title: A Comparative Study of the Application of Remimazolam, Dexmedetomidine, and Esketamine in Pediatric Preoperative Sedation
Run by Maternal and Child Health Hospital of Hubei Province · NCT07050212 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 2 Years to 5 Years |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Maternal and Child Health Hospital of Hubei Province Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Status | Recruiting |
| Started | April 1, 2025 |
| Main results expected | March 1, 2026 |
| Study ends | March 1, 2026 |
| Registry record updated | July 10, 2025 |
| Trial ID | NCT07050212 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
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
- Email: lina@hbfy.com
- Phone: +862763490107
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.