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Safety and efficacy of remazolam toluenesulfonate in pediatric outpatient sedation

Safety and efficacy of remazolam toluenesulfonate in pediatric outpatient sedation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200060800
Enrollment
Unknown
Registered
2022-06-12
Start date
2022-06-01
Completion date
Unknown
Last updated
2023-03-26

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

Conditions

sedation

Interventions

Chloral hydrate group:Take chloral hydrate
Rimazolam group:Take remazolam

Sponsors

Guangzhou Women and Children's Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 3 Years

Inclusion criteria

Inclusion criteria: 1) Aged 0-3 years; 2) Outpatient examination under sedation is planned; 3) ASA score level 1-2; 4) The legal representative of the child signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Allergic to remazolam toluenesulfonate or chloral hydrate; 2. Oropharynx or neck deformity; 3. Wheezing or phonation disorders; 4. Children who need nasogastric tube or orogastric tube; 5. Other researchers considered inappropriate to participate in this study.

Design outcomes

Primary

MeasureTime frame
Time to fall asleep;—

Secondary

MeasureTime frame
Bispectral index;Failure rate of sedation;—

Countries

China

Contacts

Public ContactBaisong Zhao

Guangzhou Women and Children's Medical Center

zhaobaisong819@163.com+86 13642665097

Outcome results

None listed

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