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Effect of Fospropofol Disodium on the Incidence of Hypotension Following General Anesthesia Induction in Elderly Patients: A Multicenter, Randomized Controlled Trial

Effect of Fospropofol Disodium on the Incidence of Hypotension Following General Anesthesia Induction in Elderly Patients: A Multicenter, Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600124747
Enrollment
Unknown
Registered
2026-05-17
Start date
2026-05-18
Completion date
Unknown
Last updated
2026-05-18

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

Conditions

Elderly patients

Interventions

Propofol Group:Intravenous injection of propofol at a dose of 1.5mg/kg within 1 minute
Phosphorylated propofol disodium Group:Intravenous injection of Phosphorylated propofol disodium at a dose of 5mg/kg within 1 minute

Sponsors

The First Affiliated Hospital of Soochow University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Age: 60 - 85 years old; 2. American Society of Anesthesiologists (ASA) grade I - III; 3. Scheduled for elective non-cardiac surgery, with tracheal intubation performed after general anesthesia; 4. Voluntary participation and signing of informed consent form.

Exclusion criteria

Exclusion criteria: 1. BMI is greater than or equal to 35 or less than 18.5; 2. Severe cardiovascular diseases (LVEF < 40%, heart failure, myocardial infarction within 90 days, severe valvular heart disease, moderate to severe pulmonary hypertension, severe arrhythmia or pacemaker dependence); 3. Preoperative systolic blood pressure is greater than or equal to 200 mmHg, diastolic blood pressure is greater than or equal to 120 mmHg; 4. Known allergy to propofol/soybean/eggs; 5. High risk of aspiration and reflux; 6. Taking antihypertensive drugs such as lisinopril that deplete neurotransmitters; 7. Liver and kidney dysfunction (Child-Pugh B/C grade or eGFR < 30 ml/min/1.73m^2); 8. Use of vasoactive drugs 24 hours before the operation; 9. Combined with nerve block anesthesia (spinal anesthesia/epidural anesthesia/lumbar epidural combined anesthesia);

Design outcomes

Primary

MeasureTime frame
The incidence of hypotension (MAP < 65 mmHg) within 15 minutes after induction;

Secondary

MeasureTime frame
Maximum mean arterial pressure;Induction success rate (without the need to use propofol for rescue);Dosage of vasoactive drugs;The incidence of hypotension (defined as a relative threshold of 30% or more decrease in blood pressure compared to the baseline) 15 minutes after induction;The time required for successful induction (from the start of administration to the disappearance of eyelash reflex);The total area under the curve of MAP < 65 mmHg within 15 minutes after induction;The incidence of injection pain;The incidence of itching;The area under the curve (AUC) for the relative threshold 15 minutes after induction (blood pressure decreased by =30% compared to baseline);Minimum mean arterial pressure;

Countries

China

Contacts

Public ContactPeng Ke;Ji Fuhai

The First Affiliated Hospital of Soochow University

pengke0422@163.com+86 512 67780156

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 22, 2026