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ED95 of Fospropofol Disodium in General Anesthesia Induction for Elderly Patients and Its Impact on Myocardial Cyclical Repolarization Dynamics

ED95 of Fospropofol Disodium in General Anesthesia Induction for Elderly Patients and Its Impact on Myocardial Cyclical Repolarization Dynamics

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600117386
Enrollment
Unknown
Registered
2026-01-23
Start date
2026-02-01
Completion date
Unknown
Last updated
2026-01-27

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

Conditions

None listed

Interventions

Induction Group:The Biased Coin Design (BCD) method was employed, starting from the initial dose and continuing until the study conclusion.
Fospropofol disodium group:Administered using the research results from Part 1 (ED95), via slow intravenous injection, with completion of administration within 60 seconds.
Propofol group:Adverse reactions

Sponsors

The Fourth People's Hospital of Guiyang City
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Patients aged >=65 years scheduled for elective surgery under general anesthesia; (2) ASA class II–III, Mallampati class I–II, BMI 18–30 kg/m²; (3) No history of allergy to anesthetic drugs; (4) No severe organ dysfunction, endocrine disorders, or metabolic diseases.

Exclusion criteria

Exclusion criteria: (1) Patients with a history of difficult airway or assessed preoperatively as difficult intubation; (2) Patients with a history of psychiatric disorders or long-term use of sedative/analgesic medications; (3) Patients with severe cardiovascular or pulmonary diseases; (4) Patients with severe hepatic or renal insufficiency; (5) Patients allergic to the investigational drug or its components; (6) Patients with long-term alcohol abuse; (7) Patients with abnormal preoperative alkaline phosphatase levels.

Design outcomes

Primary

MeasureTime frame
ED50, ED95;?PRD;? dT°;

Secondary

MeasureTime frame
mean arterial pressure, MAP;heart rate, HR;Adverse reactions;Anesthesia induction time;Anesthesia induction success rate;

Countries

China

Contacts

Public ContactYanqiu Liu

The Fourth People's Hospital of Guiyang City

1150725102@163.com+86 135 9516 1013

Outcome results

None listed

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