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Exploration of the ED50 value and appropriate administration time of alfentanil for preventing rocuronium-induced limb withdrawal movements in children: an age-stratified study

Exploration of the ED50 value and appropriate administration time of alfentanil for preventing rocuronium-induced limb withdrawal movements in children: an age-stratified study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500115111
Enrollment
Unknown
Registered
2025-12-23
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

children experiencing injection pain of rocuronium

Interventions

Group R2 (6 <= Age<12 years old):The first dose of fentanyl is 20ug/kg, and the interval between the first injection of fentanyl and rocuronium bromide is 60 seconds. By observing whether pediatric pa
Group R1 (3 <= Age<6 years old):The first dose of fentanyl is 20ug/kg, and the interval between the first injection of fentanyl and rocuronium bromide is 60 seconds. By observing whether pediatric pat
Group R4 (6 <= Age<12 years old):The first dose of fentanyl is 20ug/kg, and the interval between the first injection of fentanyl and rocuronium bromide is 60 seconds. By observing whether pediatric pa
Group R3 (3 <= Age<6 years old):The first dose of fentanyl is 20ug/kg, and the interval between the first injection of fentanyl and rocuronium bromide is 60 seconds. By observing whether pediatric pat

Sponsors

Taizhou Hospital of Zhejiang Province
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1.Children planning to undergo general anesthesia surgery; 2.age 3~12 years; 3.ASA I~II; 4.Children under 8 years old obtain consent from their guardians and sign an informed consent form; 5.Children aged 8 and above 8 years old obtain consent from the child and their guardian and sign an informed consent form;

Exclusion criteria

Exclusion criteria: 1.Patients who have history of neurological dysfunction; 2.Allergic to narcotic drugs; 3.History of asthma; 4.Unable to enter the operating room due to serious anxiety; 5.Unable to establish a good venous accessor; 6.Have taken analgesics or sedatives within 24 hours before.

Design outcomes

Primary

MeasureTime frame
rocuronium-induced withdrawal movement;ED50;Time AR50;

Secondary

MeasureTime frame
body temperature;blood pressure;Blood oxygen saturation;heart rate;

Countries

China

Contacts

Public ContactLingyang Chen

Taizhou Hospital of Zhejiang Province

chenly@enzemed.com+86 576 85120120

Outcome results

None listed

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