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To evaluate the median effective dose and safety of remimazolam in the treatment of loss of consciousness in children with congenital heart disease

To evaluate the median effective dose and safety of remimazolam in the treatment of loss of consciousness in children with congenital heart disease

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076458
Enrollment
Unknown
Registered
2023-10-09
Start date
2023-10-20
Completion date
Unknown
Last updated
2023-10-16

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

Conditions

Congenital heart disease with a left-to-right shun

Interventions

0-1years old:Different doses of remimazolam besylate were administered
1-3years old:Different doses of remimazolam besylate were administered
3-6 years old:Different doses of remimazolam besylate were administered

Sponsors

Fuwai Central China Cardiovascular Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 6 Years

Inclusion criteria

Inclusion criteria: ? =6 years old ? Planned cardiac surgery under general anesthesia ? ASA (Class ?-IV) ? Parents voluntarily sign informed consent forms

Exclusion criteria

Exclusion criteria: ? History of allergy to sedative drugs ? Preoperative use of sedative drugs other than the study drug ? Severe abnormal liver and kidney function before operation ? Preoperative respiratory diseases ? Preoperative SPO2=95%

Design outcomes

Primary

MeasureTime frame
ED50;ED95;—

Secondary

MeasureTime frame
Heart rate;Finger pulse oxygen saturation;PI;Sedation onset time;Frequency of postoperative adverse events during the perioperative period;—

Countries

China

Contacts

Public ContactHongqi Lin

Fuwai Central China Cardiovascular Hospital

1968334561@qq.com+86 135 2358 3033

Outcome results

None listed

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