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A study on the median effective dose of ciprofol for laryngeal mask anesthesia in children of different age groups

A study on the median effective dose of ciprofol for laryngeal mask anesthesia in children of different age groups

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100969
Enrollment
Unknown
Registered
2025-04-17
Start date
2025-04-23
Completion date
Unknown
Last updated
2025-04-21

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

Conditions

None

Interventions

Group A(1~3 years old):Intravenous injection of pentethylquine hydrochloride 0.01 mg/kg, sufentanil 0.3 µg/kg, 1 min, and cyclopofol were administered at an initial dose of 0.6 mg/kg for 30 seconds. T
2) No other sedative drugs are used. A maximum of three insertion attempts are allowed before endotracheal intubation is performed. According to the top-down sequential allocation method, cyclopofol w
Group B(4~6 years old):Intravenous injection of pentethylquine hydrochloride 0.01 mg/kg, sufentanil 0.3 µg/kg, 1 min, and cyclopofol were administered at an initial dose of 0.6 mg/kg for 30 seconds. T
2) No other sedative drugs are used. A maximum of three insertion attempts are allowed before endotracheal intubation is performed. According to the top-down sequential allocati

Sponsors

Women and Children's Medical Center Affiliated to Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 6 Years

Inclusion criteria

Inclusion criteria: 1. Children undergoing laryngeal mask general anesthesia, ASAI-II, regardless of gender; 2. Age: 1-6 years old; 3. Body weight 8~25 kg, BMI<30 kg/m^2.

Exclusion criteria

Exclusion criteria: 1. Children allergic to cyclopofol and opioid ingredients; Children with severe thrombocytopenia and gastrointestinal ulcers. 2. Analgesic and sedative drugs, antiemetic drugs and anti-pruritus drugs were used 24 hours before surgery; 3. Children with symptoms of acute upper respiratory tract infection before surgery; 4. Children with a history of bronchial asthma; 5. Children with severe sleep apnea syndrome and arrhythmia; 6. History of recovery from abnormal surgical anesthesia; Preoperative assessment of the presence or potential presence of difficult airways; 7. Renal function impairment (BUN and/or Cr> upper limit of normal); Liver function impairment (ALT and/or AST>1.5 times the upper limit of normal) 8. Children with related mental and neurological diseases who are difficult to evaluate the analgesic effect; 9. Children with a history of chronic pain or long-term use of painkillers; 10. Children with other conditions deemed unsuitable for inclusion by researchers.

Design outcomes

Primary

MeasureTime frame
Ciprofol unconscionable ED50 in children;Ciprofol unconscionable ED95 in children;

Countries

China

Contacts

Public ContactHuang Yaying

Guangzhou Women and Children Medical Center/Women and Children's Medical Center Affiliated to Guangzhou Medical University

huangyaying1114@126.com+86 181 9891 5617

Outcome results

None listed

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