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Safety and Efficacy of Fospropofol Disodium for Anesthesia/Sedation in Patients Undergoing Endoscopic Ultrasonography

Safety and Efficacy of Fospropofol Disodium for Anesthesia/Sedation in Patients Undergoing Endoscopic Ultrasonography

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500115027
Enrollment
Unknown
Registered
2025-12-22
Start date
2025-12-25
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Gastrointestinal diseases

Interventions

Fospropofol disodium group:None

Sponsors

Guangxi Medical University Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1: Age >= 18 years and 18 kg/m^2 and <30kg/m^2; 3: ASA class ?-?; 4: Scheduled to undergo painless upper gastrointestinal endoscopic ultrasonography; 5: Voluntarily participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1: Known allergy to the investigational drug(s) or any of their components; 2: Severe hepatic insufficiency (Child-Pugh class B or C) or severe renal impairment (estimated glomerular filtration rate [eGFR] = 3), diagnosed sleep apnea syndrome, or severe respiratory disease (e.g., resting SpO2 = 160 mmHg or diastolic blood pressure >= 100 mmHg) or uncontrolled hypotension (systolic blood pressure = III, acute myocardial infarction within the past 6 months); 5: Pregnancy or lactation; 6: Chronic regular use (e.g., > 3 times per week within 4 weeks prior to enrollment) of sedative-hypnotics, opioids, antidepressants, anxiolytics, or antipsychotic medications; 7: Recent history (e.g., within 3 months) of drug or alcohol abuse; 8: The presence of any other condition that may affect the reliable assessment of study outcomes (e.g., communication barriers, inability to cooperate with the required assessments); 9: Exclusively scheduled for transcolonic endoscopic ultrasonography.

Design outcomes

Primary

MeasureTime frame
Procedure Completion Rate;

Secondary

MeasureTime frame
Emergence Time;Incidence of Bradycardia;Total Consumption of the Study Drug;Incidence of Injection Pain;Number of Supplemental Doses of the Study Drug;Incidence of Hypoxemia;Sedation Onset Time;Incidence of Hypotension;Patient Satisfaction;Operator Satisfaction;Incidence of Pruritus;Time to Meet Discharge Criteria;Incidence of Postoperative Nausea and Vomiting;

Countries

China

Contacts

Public ContactFei Lin

Guangxi Medical University Cancer Hospital

linfei@gxmu.edu.cn+86 771 534 7259

Outcome results

None listed

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