The Second Affiliated Hospital of Zhejiang University anesthesiology department
Hangzhou, Zhejiang, 310000, China
Location status: Recruiting
NCT Number: NCT06952608
The prevention of intraoperative hypotension could reduce postoperative organ injury and mortality, particularly in elderly patients receiving long-term renin-angiotensin system inhibitors. Previous meta-analyses suggest that ciprofol, a novel intravenous anesthetic agent, may provide improved hemodynamic stability compared to propofol; however, its precise effects on perioperative hemodynamics remain unclear. The study will assess whether ciprofol improves perioperative hemodynamic stability in elderly patients receiving renin-angiotensin system inhibitors.
Interested in participating?
Request Info65 year and older
All sexes
Interventional
Phase 4
Hangzhou, Zhejiang, 310000, China
Location status: Recruiting
Elderly patients receiving long-term renin-angiotensin system inhibitors commonly exhibit reduced vascular elasticity, impaired cardiovascular reserve, and diminished compensatory mechanisms. Regular use of renin-angiotensin system inhibitors has thus emerged as a significant risk factor for intraoperative hypotension, increasing the potential for end-organ injury and closely correlating with postoperative complications such as myocardial injury, acute kidney injury, and increased mortality.
Ciprofol (HSK3486) is a novel intravenous anesthetic agent that has demonstrated efficacy non-inferior to propofol for induction and maintenance of general anesthesia, with an improved safety profile and fewer adverse effects. Recent meta-analyses indicate that ciprofol administration is associated with a significantly reduced incidence of intraoperative hypotension compared with propofol; however, robust evidence from randomized controlled trials (RCTs) remains limited. The present study aims to evaluate the impact of ciprofol on perioperative hemodynamics in elderly patients receiving renin-angiotensin system inhibitors. Given the increased risk of intraoperative hypotension in this patient cohort, the investigation of hemodynamic stability with ciprofol holds substantial clinical significance and may inform anesthetic management strategies for this vulnerable population.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Body mass index ≤18 or ≥35 kg/m².
General anesthesia induction and maintenance were performed using ciprofol.
General anesthesia induction and maintenance were performed using propofol.
Time frame: From the beginning to the end of the surgery
The time-weighted average is measured by calculating the area under the threshold (AUT) divided by the total duration of surgery
Time frame: within 15 minutes after induction of anesthesia
The time-weighted average is measured by calculating the area under the threshold (AUT) divided by the total duration of induction.
Time frame: From the beginning to the end of the surgery
Time frame: From the beginning to the end of the surgery
Time frame: From the beginning to the end of the surgery
MOAA/S score of 1 or less after administration of ciprofol or propofol, 1 or fewer top-up doses, and no use of rescue drug
Time frame: From the beginning to the end of the surgery
Time frame: From the beginning to the end of the surgery
Time frame: From start of drug administration to MOAA/S ≤1 (up to 5 minutes)
Time frame: Perioperative
Time frame: From the beginning to the end of the surgery
Time frame: during the PACU stay
Time frame: Periprocedural
Time frame: Intraoperative
Nomal value:≤10%,and higher scores mean a worse outcome.
Time frame: Intraoperative
Nomal value:2.5-4.0 L/min/m²,and values outside the normal range suggest worse clinical outcomes
Time frame: Intraoperative
Nomal value :1970-2390 dyn·s·cm-⁵·m²,and values outside the normal range suggest worse clinical outcomes
Time frame: Intraoperative
Time frame: From enrollment to the end of treatment at 3 months
delirium, myocardial injury, stroke, acute kidney injury, infection, sepsis, etc.
Time frame: 3 day after surgery
Time frame: Periprocedural
RASS&CAM-ICU, delirium was judged according to whether there were positive features in the questionnaire
Contact information is provided by the study sponsor or research team.
Second Affiliated Hospital, School of Medicine, Zhejiang University
Other
The Effect of Ciprofol on Intraoperative Hypotension in Elderly Patients Receiving Renin-angiotensin System Inhibitors: a Prospective, Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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