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NCT07663695
Propofol vs. Ciprofol for Anesthesia Induction in Frail Elderly Patients
Conditions: Hypotension
Sex: All
Ages: 60 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 96
Sponsor: General Hospital of Ningxia Medical University
Location: General Hospital of Ningxia Medical University Yinchuan Ningxia
Summary
Post-induction hypotension (PIH) is a common and critical complication during general anesthesia, particularly in frail elderly patients whose physiological reserves are significantly diminished. PIH is strongly associated with adverse postoperative outcomes, including acute kidney injury (AKI) and myocardial injury. Propofol is the most widely used induction agent but frequently induces circulatory depression. Ciprofol, a novel anesthetic agent developed by optimizing the molecular structure of propofol, has demonstrated improved hemodynamic stability and fewer adverse effects in general populations. However, its specific impact on frail elderly patients remains unestablished.
The primary purpose of this single-center, randomized, double-blind, controlled trial is to compare the effects of propofol and ciprofol during anesthesia induction on the incidence of PIH in frail elderly patients undergoing major abdominal surgery. The investigator's hypothesis is that ciprofol will significantly lower the incidence of PIH compared to propofol. Additionally, the study will evaluate secondary clinical outcomes, such as postoperative AKI, postoperative cardiac complications, and the overall quality of recovery, to provide an evidence-based clinical guide for selecting optimal induction agents for this vulnerable patient population.
Eligibility Criteria
Inclusion Criteria:
* Patients scheduled to undergo major abdominal surgery under general anesthesia.
* Frailty score \>= 3\[cite: 2\].
* Age \>= 60 years\[cite: 2\].
* American Society of Anesthesiologists (ASA) physical status class \>= II\[cite: 2\].
* Planned invasive blood pressure monitoring\[cite: 2\].
Exclusion Criteria:
* Severe cardiac arrhythmia\[cite: 2\].
* Severe valvular heart disease\[cite: 2\].
* Poorly controlled hypertension with medication (systolic blood pressure \>= 180 mmHg and/or diastolic blood pressure \>= 110 mmHg)\[cite: 2\].
* Pre-existing preoperative hypotension (mean arterial pressure \< 65 mmHg)\[cite: 2\].
* Preoperative renal dysfunction (serum creatinine greater than the upper limit of normal)\[cite: 2\].
Source: ClinicalTrials.gov (NCT07663695). StuddyBuddy aggregates publicly available trial information.