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A Comparison of the Efficacy and Safety of Fospropofol Disodium versus Propofol for Anesthesia in Pediatric Brief Digestive Endoscopy Procedures

A Comparison of the Efficacy and Safety of Fospropofol Disodium versus Propofol for Anesthesia in Pediatric Brief Digestive Endoscopy Procedures

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600128960
Enrollment
Unknown
Registered
2026-07-29
Start date
2026-07-30
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Diseases that require pediatric gastrointestinal endoscopy

Interventions

The fospropofol disodium group (Group F):After the child was admitted to the room and given routine monitoring, a single dose of 10 µg/kg of alfentanil was slowly injected intravenously under nasal ca
Propofol Group (Group P):After the child was admitted to the room and given routine monitoring, a single dose of 10 µg/kg of alfentanil was slowly injected intravenously under nasal cannula oxygen sup

Sponsors

Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 17 Years

Inclusion criteria

Inclusion criteria: 1.Age 3–17 years; 2.No gender restrictions; 3.ASA class I–II; 4.Undergoing digestive endoscopy under non-intubated general anesthesia; 5.Family members have signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Known or suspected allergy to propofol or any drug specified in this trial; 2. Requiring special care or supervision from a court or social welfare institution; 3. Received general anesthesia within 14 days prior to the experiment; 4. Participated in clinical trials of other drugs within 3 months before screening; 5. Comorbidity with other serious diseases, including severe cardiovascular disease, severe anemia, liver or kidney dysfunction, neurological disorders (including cognitive impairment or epilepsy), or acute angle-closure glaucoma; 6. Presence of relatively serious respiratory issues.

Design outcomes

Primary

MeasureTime frame
Sedation success rate after the first dose;

Secondary

MeasureTime frame
Postoperative Recovery Quality Indicators;Induce quality-related indicators;Intraoperative safety indicators;;Anesthesia/Sedation Satisfaction Score.;

Countries

China

Contacts

Public ContactDai Shiyun

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

ldsy0930@163.com+86 21 38626161

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026