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Study on the effectiveness, safety and serum concentration of fospropofol disodium in anesthesia induction in patients undergoing cardiac surgery

Study on the effectiveness, safety and serum concentration of fospropofol disodium in anesthesia induction in patients undergoing cardiac surgery

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093011
Enrollment
Unknown
Registered
2024-11-27
Start date
2024-11-30
Completion date
Unknown
Last updated
2024-12-02

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

Conditions

Success rate of anesthesia induction

Interventions

Fospropofol disodium group:Induction of anaesthesia with disodium fospropofol
Etomidate group:Etomidate induction of anaesthesia

Sponsors

The First Affiliated Hospital of Xi'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Patients who are planning to undergo coronary artery bypass grafting, valve replacement, or elective thoracic major vascular surgery; 2.Age 18-65, no gender limit; 3.18kg/m2<BMI<30kg/m2; 4.NYHA heart function class II-IV; 5.ASA classification III or above;

Exclusion criteria

Exclusion criteria: 1.Severe cardiovascular instability (acute heart failure, myocardial infarction, etc.); 2.Poorly controlled hypertension; 3.Patients with liver and renal dysfunction; 4.Allergic to fospropofol disodium or etomidate; 5.Participated in another study within 4 weeks before the current trial; 6.Drug and alcohol abuse patients; 7.Pregnant and lactating patients; 8.Patients using QT interval prolongation drugs in the 3 months prior to surgery;

Design outcomes

Primary

MeasureTime frame
Success rate of anesthesia induction 5 minutes after sedation;

Secondary

MeasureTime frame
Time from intubation to anesthesia maintenance;Blood pressure and the incidence of hypertension, hypotension, bradycardia, and tachycardia;BIS value;Output volume, peripheral circulatory resistance, stroke volume variability;Frequency and total dose of vasoactive drugs;Incidence of adverse reactions: paresthesia during induction, injection pain, muscle tremor, awareness during surgery;Adverse reactions during the induction period: paresthesia, injection pain, muscle tremor, etc.;

Countries

China

Contacts

Public ContactYaomin Zhu

The First Affiliated Hospital of Xi'an Jiaotong University

zhuyaomin_mzk@163.com+86 18629382846

Outcome results

None listed

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