A study of remimazolam in children's individualized drug regimen:based on PK/PD model and genomics.

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000033381

Enrollment

Unknown

Registered

2020-05-30

Start date

2020-06-01

Completion date

Unknown

Last updated

2020-06-01

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

Conditions

ICU patient

Interventions

Group 1 vs Group 2:intravenous infusion vs. continuous intravenous pump

Sedation success group vs.Sedation failure group:N/A

Eligibility

Sex/Gender

All

Age

No minimum to 6 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 0-6 years old who need to enter ICU for further observation and treatment after general anesthesia operation; 2. ASA (American Society of Anesthesiologists physical status score) level I ~ III; 3. BMI 18-30 kg/m2.

Exclusion criteria

Exclusion criteria: 1. Patients who are known to be sensitive to flumazenil, a benzodiazepine drug, and naloxone, a opioid drug, or patients with contraindications; 2. Patients with airway management difficulties, such as the distance between nail and chin 33 kg / m2) with ASA score of III.

Design outcomes

Primary

Measure	Time frame
Plasma drug concentration of remimazolam;	—

Secondary

Measure	Time frame
the success rates of sedation;	—

Countries

China

Contacts

Public ContactBilian Li

Anesthesia Department of Guangzhou Women and Children's Medical Centre

13570226780@126.com+86 13570226780

Outcome results

None listed

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