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Effect of Fospropofol for General Anesthesia Induction on Post-Induction Hypotension in Elderly Patients: A Single-Center, Randomized, Double-Blind, Controlled Trial

Effect of Fospropofol for General Anesthesia Induction on Post-Induction Hypotension in Elderly Patients: A Single-Center, Randomized, Double-Blind, Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114510
Enrollment
Unknown
Registered
2025-12-14
Start date
2025-06-02
Completion date
Unknown
Last updated
2025-12-15

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

Conditions

None

Interventions

Fospropofol Group:intravenous injection of fospropofol during general anesthesia induction.
Propofol Group:intravenous injection of propofol during general anesthesia induction.

Sponsors

Hainan Medical University Hainan Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Over 65 years, gender unrestricted; (2) ASA physical status I-III; (3) BMI 18.5–30 kg/ m^2; (4) Scheduled for elective surgery under general anesthesia with an expected surgery duration > 30 minutes; (5) Excluding cardiac surgery, emergency surgery, and maternal surgery; (6) Willing to participate and signed the informed consent form.

Exclusion criteria

Exclusion criteria: (1) History of general anesthesia contraindications or previous anesthesia-related accidents (2) Complicated with cranial trauma, intracranial hypertension, stroke, unstable angina, myocardial infarction, or carotid artery stenosis (3) Severe cardiac dysfunction (cardiac function grade III-IV) or history of valvular heart disease (4) Hypotensive patients requiring vasoconstrictor therapy before surgery, patients with left ventricular ejection fraction < 50%, patients with non-sinus rhythm, pulmonary hypertension patients (5) Respiratory insufficiency, obstructive pulmonary disease, difficult airway, or (modified Mallampati score III or IV) (6) Uncontrolled diabetes or hypertension (7) History of drug abuse, alcoholism, or substance dependence (8) Abuse or long-term use of anesthetics, sedatives, or analgesics (9) Individuals who are known or suspected to be allergic or contraindicated to various components of the investigational drug or the prescribed process drugs in the protocol (sufentanil citrate injection, propofol medium/long-chain fat emulsion, remifentanil hydrochloride injection, propofol disodium injection); (10) Individuals with a history of severe cognitive impairment, neurological disorders, or mental illness; (11) Individuals who have participated in any drug clinical trials within the past month prior to screening; (12) The experimenter believes that there are any other factors that are not suitable for participants in this experiment; Patients who refuse to participate in this trial.

Design outcomes

Primary

MeasureTime frame
Post-induction hypotension incidence;

Secondary

MeasureTime frame
Perioperative vital organ function markers;Post-induction hypotension episodes;Adverse events: Injection painParesthesia ArrhythmiaNausea and vomitingVenous irritationShiveringMuscle rigidity CoughingAgitationRespiratory depressionDelayed recoveryIntraoperative awarenes;Hemodynamic parameters at different time points (SBP, DBP, MAP, HR, CO, SVV);Quality of Recovery-15 (QoR-15) score;Time-related outcomes: Eye-opening timeRecovery timePACU length of stayPostoperative hospital stay;

Countries

China

Contacts

Public ContactWei Gao

Hainan Medical University Hainan Hospital

gaowei20055@126.com+86 138 3617 2191

Outcome results

None listed

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