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Fospropofol Disodium Versus Propofol for Perioperative Hemodynamic Stability in Elderly Patients Undergoing Total Knee Arthroplasty: A Randomized Controlled Trial

Fospropofol Disodium Versus Propofol for Perioperative Hemodynamic Stability in Elderly Patients Undergoing Total Knee Arthroplasty: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600116079
Enrollment
Unknown
Registered
2026-01-05
Start date
2026-01-15
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

Hemodynamic instability

Interventions

Fospropofol Disodium Group:During anesthetic induction, fospropofol disodium was administered intravenously by slow injection at a dose of 12 mg/kg over 60 seconds until the bispectral index (BIS) dec
Propofol Group:During anesthetic induction, propofol was administered intravenously by slow injection at a dose of 1.5 mg/kg over 30 seconds until the bispectral index (BIS) decreased to 40–60. This w

Sponsors

Fuyang People’s Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >= 65 years, any gender; 2. ASA classification II–III; 3. Planned elective unilateral total knee arthroplasty to be performed under general anesthesia; 4. Preoperative assessment shows no severe heart, lung, liver, or kidney dysfunction, and the patient can tolerate general anesthesia; 5. The participant and their family voluntarily agree to participate in the study and sign a written informed consent form.

Exclusion criteria

Exclusion criteria: 1. Severe respiratory or circulatory system diseases, such as NYHA class III or above, recent (within 3 months) myocardial infarction, chronic respiratory failure, or active pulmonary infection; 2. Severe liver or kidney dysfunction (ALT or AST > 3 times the upper limit of normal, or eGFR < 45 mL/min/1.73 m²); 3. Comorbid cerebrovascular or neurological diseases (such as Parkinson's disease, epilepsy, etc.) that may affect anesthesia assessment; 4. Allergy to propofol, fospropofol disodium, or related substances (including lecithin, soy products, etc.); 5. Use of beta-blockers, lidocaine, or other medications that affect circulatory stability and cannot be discontinued; 6. Severe preoperative anemia (Hb < 90 g/L) or hypovolemic state; 7. History of drug abuse; 8. Other conditions that the researcher deems unsuitable for enrollment.

Design outcomes

Primary

MeasureTime frame
The incidence of hemodynamic instability events;

Secondary

MeasureTime frame
The incidence of individual hemodynamic instability events;The incidence of drug-related adverse events;Pain scores and analgesic requirements;

Countries

China

Contacts

Public ContactXiaofeng Wang

Fuyang People’s Hospital

wxf682610@163.com+86 157 0558 2601

Outcome results

None listed

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