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The ED50 of Ciprofol Combined with Fentanyl for Suppressing Tracheal Intubation Response in Pediatric Laparoscopic Hernia Surgery

The ED50 of Ciprofol Combined with Fentanyl for Suppressing Tracheal Intubation Response in Pediatric Laparoscopic Hernia Surgery

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500098764
Enrollment
Unknown
Registered
2025-03-13
Start date
2025-03-13
Completion date
Unknown
Last updated
2025-03-17

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

Conditions

indirect inguinal hernia

Interventions

Age group: 3-6 years:Initial dose of ciprofol: 0.6 mg/kg.
Age group: 7-12 years:Initial dose of ciprofol: 0.6 mg/kg.

Sponsors

The Second Affiliated Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1.Age range: 3 to 12 years. 2.Body mass index (BMI) ranges: 13.6-18.2 kg/m^2 for ages 3-4 years, 14.0-19.3 kg/m² for ages 5-7 years, 14.7-20.4 kg/m^2 for ages 8-10 years, and 15.4-22.4 kg/m^2 for ages 11-12 years. 3.American Society of Anesthesiologists (ASA) physical status classification I-II. 4.Normal developmental status. 5.Informed consent was obtained from the legal guardians of the children prior to anesthesia.

Exclusion criteria

Exclusion criteria: 1.Allergy to ciprofol or propofol. 2.Confirmed difficult airway. 3.Ongoing sedative therapy (e.g., propofol, morphine, fentanyl, sufentanil, midazolam, dexmedetomidine, ketamine) or recent use of sedatives (withdrawal time <24 hours). 4.Cardiac or respiratory diseases. 5.Hepatic or renal dysfunction. 6.Developmental malformations or delays. 7.If any of the above answers is "No," the subject is excluded from participation.

Design outcomes

Primary

MeasureTime frame
The ED50 and ED95 of ciprofol for suppressing the tracheal intubation response;

Secondary

MeasureTime frame
Incidence of adverse effects;Systolic Blood Pressure (SBP);Diastolic Blood Pressure (DBP);Heart Rate (HR);Respiratory Rate (RR);Onset Time of Sedation;

Countries

China

Contacts

Public ContactRuifeng Zeng

Department of Anesthesiology, The 2nd Affiliated Hospital of Wenzhou Medical University

ruifengzeng@163.com+86 138 5773 4776

Outcome results

None listed

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