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ED50 and ED95 of Ciprofol for Loss of Consciousness During Anaesthetic Induction in Children: A Prospective Sequential Dose-Finding Study

ED50 and ED95 of Ciprofol for Loss of Consciousness During Anaesthetic Induction in Children: A Prospective Sequential Dose-Finding Study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600126143
Enrollment
Unknown
Registered
2026-06-04
Start date
2026-06-04
Completion date
Unknown
Last updated
2026-06-08

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

Conditions

Induction of general anesthesia

Interventions

Trial group:The initial dose was set at 0.4 mg/kg. The next dose was determined by the "Biased Coin Design Up-and-Down Sequential Method", with a dose interval of 0.05 mg/kg. If a subject failed to ac

Sponsors

Shanghai Sixth People’s Hospital Afffliated to Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Age 8 to 12 years; 2. ASA physical status I–II; 3. Body mass index (BMI) between the 5th and 85th percentiles.

Exclusion criteria

Exclusion criteria: 1. Hepatic or renal dysfunction, and cardiovascular or endocrine disorders; 2. History of allergy to propofol or remimazolam; 3. Upper respiratory tract infection within the past 4 weeks; 4. History of developmental delay, autism spectrum disorder, or other psychiatric conditions.

Design outcomes

Primary

MeasureTime frame
ED50ED95;

Secondary

MeasureTime frame
Injection pain during the induction period; Hypotension; Respiratory depression;Hypoxia;Choking cough; Laryngeal spasm;Bradycardia;

Countries

China

Contacts

Public ContactYao Jiahui

Shanghai Sixth People’s Hospital Afffliated to Shanghai Jiao Tong University School of Medicine

277217137@qq.com+86 189 3017 6453

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026