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The Efficacy and Safety of Combination of Ciprofol-Fentanyl in Preschool Children Undergoing Gastrointestinal Endoscopy

The Efficacy and Safety of Combination of Ciprofol-Fentanyl in Children Undergoing Gastrointestinal Endoscopy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064926
Enrollment
Unknown
Registered
2022-10-23
Start date
2022-10-22
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

procedural sedation for gastrointestinal endoscopy

Interventions

Group 1:a bolus cyprofol of 0.8 mg/kg
Group 2:a combination of intravenous 0.75 mg/kg cyprofol and 0.25 ug/kg fentanyl
Group 3:a combination of intravenous 0.7 mg/kg cyprofol and 0.5ug/kg fentanyl
Group 4:a combination of intravenous 0.65 mg/kg cyprofol and 0.75ug/kg fentanyl
Group 5:a combination of intravenous 0.6 mg/kg cyprofol and 1ug/kg fentanyl

Sponsors

Department of Anesthesiology, Shanghai Childre's Medical Center Affiliated to School of Medicine, Shanghai Jiao Tong University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Pediatric patients aged 3-12 years, with ASA I-III, who were scheduled for elective gastrointestinal endoscopy.

Exclusion criteria

Exclusion criteria: Weight less than 10 kg, severe gastroesophageal reflux disease and other risk of vomiting, oral sedative drugs used within 24 hours, active gastric bleeding, obesity (BMI > 35 kg/m2), mental or neurological diseases, presence of Liver, kidney and other important organs were damaged and there was allergy to propofol in the past.

Design outcomes

Primary

MeasureTime frame
90% Effective Dose of Cyprofol;

Secondary

MeasureTime frame
procedural tolerance using a 10-point visual analog scale;the lowest value of BIS;mean blood pressure;heart rate;periepheric oxygen saturation;numbers and times of BIS < 40;recovery time;postoperative emergence and delirium assessment using PAEDS scale;pain assessment using FLACC scale score in the PACU;

Countries

China

Contacts

Public ContactZheng Jijian

Shanghai Children's Medical Center Affiliated to School of Medicine, Shanghai Jiao Tong University

Zhengjijian626@sina.com+86 18964853803

Outcome results

None listed

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