Comparison of the efficacy of intranasal atomised remimazolam versus intranasal atomised esketamine as a premedication for sedation and anxiolysis in children

Clinical application of remimazolam in pediatric anesthesia

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500097537

Enrollment

Unknown

Registered

2025-02-20

Start date

2025-02-27

Completion date

Unknown

Last updated

2025-02-24

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

Conditions

Separation anxiety

Interventions

Remazolam group (group R):Intranasal atomization of 1.5mg/kg remimazolam

Esketamine group(group S):Intranasal atomised 1mg/kg esketamine

Saline group (group C):Intranasal normal 0.05ml/kg saline

Eligibility

Sex/Gender

All

Age

1 Years to 6 Years

Inclusion criteria

Inclusion criteria: 1.Age 1-6 years old; 2.ASA ? - ?; 3.The weight of children of the same age ranges from 25% to 75%.

Exclusion criteria

Exclusion criteria: 1.There was a history of respiratory tract infection within 2 weeks; 2.Have a history of nervous system disease, mental disease, cardiopulmonary disease; 3.Abnormal liver and kidney function; 4.Children with allergies to the drugs used in the study.

Design outcomes

Primary

Measure	Time frame
Modified Yale Preoperative Anxiety Scale, m-Ypas score;	—

Secondary

Measure	Time frame
Calmness level;Acceptance of nasal administration;Parental Separation Anxiety Scal, PSAS;Mask Acceptance Score, MAS;Satisfaction assessment;Incidence of Emergence Agitation;Wake-up time;Recovery time;	—

Countries

China

Contacts

Public ContactWu Meichao

Fuyang People's Hospital

ksly0501@163.com+86 181 1053 1585

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026