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median effective dose and 95% effective dose of Remazolam for preoperative sedation in children of different age groups

median effective dose and 95% effective dose of Remazolam for preoperative sedation in children of different age groups

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074480
Enrollment
Unknown
Registered
2023-08-08
Start date
2023-09-01
Completion date
Unknown
Last updated
2023-08-21

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

Conditions

procedural sedation of children

Interventions

Test group :Remazolam

Sponsors

Guangzhou Women's and Children's Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 6 Years

Inclusion criteria

Inclusion criteria: ? Gender is not limited; ? The age ranges from 1 to 6 years old; ? American Society of Anesthesiologists (ASA) Grades I, II; ?Standard BMI corresponding to age and sex; ?Elective surgery under quasi-general anesthesia; ? Preoperative anxiety was not relieved after the use of non-drug intervention.

Exclusion criteria

Exclusion criteria: ? Allergies to benzodiazepines and remidazolam; ? Myasthenia gravis patients; ? Schizophrenic patients; ? Severe depressive state; ? Malnutrition or obesity; ? Liver dysfunction; ? Having upper respiratory tract diseases; ? Central nervous system dysfunction; ? Congenital heart defect; ? Recently used other analgesics and sedatives; ? The child's guardian refuses; ? Unable to establish peripheral venous access in the ward.

Design outcomes

Primary

MeasureTime frame
drug dose when children's PSAS=1;

Secondary

MeasureTime frame
Vital signs such as heart rate, blood pressure, and pulse oxygen saturation;MOAA/S score;MAS score;

Countries

China

Contacts

Public ContactChen Xi

Guangzhou Women's and Children's Medical Center

877579351@qq.com+86 186 2068 8567

Outcome results

None listed

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