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Intranasal remimazolam tosilate for premedication in children

Comparison of intranasal remimazolam tosilate and midazolam for premedication in children: an non-inferiority, randomized, double-blind study

Status
Unknown
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000038161
Enrollment
Unknown
Registered
2020-09-11
Start date
2020-10-01
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

preoperative anxiety

Interventions

remimazolam 0.2mg/kg:intranasal remimazolam, 0.2mg/kg
remimazolam 0.4mg/kg:intranasal remimazolam, 0.4mg/kg
midazolam 0.2mg/kg:intranasal midazolam, 0.2mg/kg

Sponsors

Fujian Provincial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 7 Years

Inclusion criteria

Inclusion criteria: 1.Scheduled for elective tonsillectomy; 2.Aged 3-7 years; 3.With American Society of Anesthesiologists (ASA) physical status I or II.

Exclusion criteria

Exclusion criteria: 1. Allergic to Benzodiazepines; 2. With acute upper respiratory infection,circulation dysfunction,liver dysfunction,kidney dysfunction and other important organ dysfunction; 3. Unable to cooperate with trial for any reason,such as refusing to intranasal remimazolam,a history of psychiatric disorder and so on.

Design outcomes

Primary

MeasureTime frame
sedation level;—

Secondary

MeasureTime frame
the onset time of sedation;parental separation anxiety;acceptance of mask induction;emergence time;emergence delirium;postoperative pain intensity;length of stay in the PACU;adverse effects;—

Countries

China

Contacts

Public ContactYusheng Yao

Fujian Provincial Hospital

fjslyys@126.com+86 13559939629

Outcome results

None listed

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