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Effective doses of ciprofol combined with fentanyl for inhibition the response of laryngeal mask insertion in pediatric inguinal hernia repair surgery

Effective doses of ciprofol combined with fentanyl for inhibition the response of laryngeal mask insertion in pediatric inguinal hernia repair surgery

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058954
Enrollment
Unknown
Registered
2022-04-20
Start date
2022-05-01
Completion date
Unknown
Last updated
2024-02-05

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

Conditions

None listed

Interventions

C0 Group:The initial dosage of ciprofol was 1.6mg/kg ,an increment or decrement of 0.05mg/kg was made based on the previous patients "three-point, six-category scale" response to the first attempt of
C1 Group:2min after 1ug/kg fentanyl, the initial dosage of ciprofol was 0.6mg/kg , An increment or decrement of 0.05mg/kg was made based on the previous patients response to the first attempt of LMA i
C2 Group:2min after 2ug/kg fentanyl, the initial dosage of ciprofol was 0.6mg/kg , An increment or decrement of 0.05mg/kg was made based on the previous patients response to the first attempt of LMA i

Sponsors

The 2nd Affiliated Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 6 Years

Inclusion criteria

Inclusion criteria: 1. Prior to the commencement of any activities related to the study, the subject's legal guardian shall obtain informed consent, be fully aware of the purpose and significance of the study, and be willing to comply with the test protocol; 2. Preschool children aged 3-6 years; 3. American Anesthesiologist Grade (ASA) I; 4. Subjects undergoing laparoscopic pediatric hernia repair under general anesthesia; 5. Meet the weight criteria.

Exclusion criteria

Exclusion criteria: 1. Difficult airway and severe respiratory diseases, acute respiratory infections, uncontrolled asthma and unexplained dyspnea; 2. Paediatric populations in need of special care or supervision by courts/social welfare institutions; 3. Subjects with mental system diseases, cognitive dysfunction, and epilepsy history; 4. Subjects with cardiovascular diseases (such as congenital heart disease, bradycardia requiring treatment, hypotension requiring treatment, etc.); 5. Subjects with abnormal liver function, ALT and/or AST>1.5 times the upper limit of normal; Subjects whose total bilirubin exceeds the upper limit of normal; Subjects with abnormal renal function and serum creatinine exceeding the upper limit of normal; 6. Use of sedative hypnotics (including benzodiazepines such as diazepam and barbiturates such as phenobarbital) or other analgesics (such as systematic use of NASIDs) within 7 days before surgery; 7. Participated in other clinical trials (received test drug or placebo) within 3 months before surgery; 8. Allergic to propofol, opiates and other drug ingredients or components; 9. Other conditions deemed unsuitable for participation in this clinical trial by the investigator.

Design outcomes

Primary

MeasureTime frame
the ED50 of ciprofol in three group;

Secondary

MeasureTime frame
consciousness loss time (MOAA/S =1) after ciprofol injection;mean blood pressure;heat rate;pulse oxygen saturation;Awakening time in PACU;

Countries

China

Contacts

Public ContactShangguan Wangning

The 2nd Affiliated Hospital of Wenzhou Medical University

sgwning@163.com+86 135 8763 7891

Outcome results

None listed

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