Study on the Effective Doses ED50 and ED90 of Remimazolam for Preoperative Sedation in Children Undergoing Tonsillectomy and Adenoidectomy

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2600128817

Enrollment

Unknown

Registered

2026-07-27

Start date

2026-08-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tonsillar and/or adenoid hypertrophy

Interventions

ED50 of the 3–5 years group Part One (ED50):intravenous remimazolam sedation Based on the Dixon up-and-down method

ED50 of the 6–12 years group Part One (ED50):intravenous remimazolam sedation Based on the Dixon up-and-down method

ED90 of the 3–5 years group Part Two (ED90):intravenous remimazolam sedation Designed based on BCD-UD

ED90 of the 6–12 years group Part Two (ED90):intravenous remimazolam sedation Designed based on BCD-UD

Eligibility

Sex/Gender

All

Age

3 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1.Age: 3–5 years or1 6-12 years; 2.Scheduled for elective tonsillectomy ± adenoidectomy under general anesthesia; 3.ASA physical status I–II; 4.Written informed consent signed by the legal guardian; for children aged 8 years and older, age-appropriate assent shall be provided and obtained;

Exclusion criteria

Exclusion criteria: 1. Allergic to benzodiazepines or related excipients; 2. Severe heart or lung dysfunction; 3. Acute respiratory infection within the past 2 weeks; 4. Congenital liver or kidney dysfunction; 5. Neuromuscular diseases, cerebral palsy, or epilepsy; 6. Difficult airway (considered difficult if any two of the following are met: Mallampati grade III-IV; mouth opening = 30; history of difficult intubation or mask ventilation); 7. Patients expected to need ICU admission after surgery; 8. Participating in other interventional studies that may affect this study's outcomes; 9. Other conditions deemed unsuitable by the investigator; 10. Weight < 12 kg.

Design outcomes

Primary

Measure	Time frame
parent-child separation score;	—

Secondary

Measure	Time frame
Incidence of perioperative respiratory adverse events,PRAEs;circulatory events;degree of cooperation during induction;depth of sedation;PACU outcomes;	—

Countries

China

Contacts

Public ContactLifei Liu

Children's Hospital of Chongqing Medical University

54099645@qq.com+86 23 6363 2143

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026