Elderly patients are frequently burdened with age-associated comorbidities and frailty, accompanied by physiological changes such as vascular stiffening, cardiac dysfunction, and impaired autonomic regulation. These factors not only increase the risk of adverse perioperative outcomes but also heighten sensitivity to anesthetic agents, making elderly patients particularly susceptible to anesthesia-related complications, especially hypotension. Consequently, optimizing anesthesia strategies for this high-risk population has become a critical goal in perioperative management. Titrated anesthesia, which individualizes anesthetic drug delivery based on patient response to achieve predefined endpoints, offers a potential approach to mitigating anesthetic risks. Ciprofol, a novel intravenous anesthetic, has been associated with less hemodynamic suppression compared with traditional agents; however, higher single doses may still predispose patients to hypotension. Remifentanil, an ultra-short-acting opioid, exerts significant cardiovascular depressive effects, further contributing to perioperative hypotension. It is hypothesized that titrated administration of anesthetic agents during both the induction and maintenance phases, compared with conventional fixed-dose protocols, may reduce the incidence of perioperative hypotension in elderly patients.
This study aims to investigate whether titrated anesthesia can provide more stable hemodynamic conditions during surgery and whether this approach is associated with improved postoperative recovery in elderly patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
500
Anesthesia induction and maintenance will be performed with ciprofol and remifentanil. During the entire procedure, infusion rates will be adjusted according to a target BIS value of approximately 50, with anesthetic dosing continuously modified in response to BIS monitoring. The attending anesthesiologist will titrate anesthetic delivery based on BIS guidance rather than routine clinical judgment alone.
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Incidence of intraoperative hypotension.
Hypotension is defined as at least one episode of mean arterial pressure (MAP) \<65 mmHg sustained for at least 1 minute.
Time frame: From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.
the time-weighted area under the curve (TWA) for MAP <65 mmHg during the anesthesia period
calculated as AUC / total time of anesthesia
Time frame: From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.
cumulative dose of norepinephrine and the proportion of patients requiring vasoactive support;
the cumulative dose of norepinephrine administered intraoperatively (µg) and the proportion of patients who required any vasoactive medication (norepinephrine, dopamine, or ephedrine) during the anesthesia period.
Time frame: From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.
the time-weighted area under the curve (TWA) for MAP <0.8 baseline during the anesthesia period
caculate as area under the curve / total anesthesia time
Time frame: From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.
Time to first hypotension
The time to first hypotension during anesthesia
Time frame: From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.
CI trend during anesthesia
CI data will be collected by the device and extracted for analysis.
Time frame: From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.
The time periods with a higher incidence of hypotension between the two groups
The time is divided into four parts: induction period, post-induction period, surgical period, and early postoperative period
Time frame: From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.
Total dose of ciprofol and remifentanil during surgery
The total doses of ciprofol and remifentanil administered per hour throughout the entire surgical procedure.
Time frame: From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.
Whether blood pressure variability (CV) and the average rate of blood pressure variation (ARV) are different.
Both CV and ARV will be calculated using the formulas provided in the reference literature.
Time frame: From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.
The incidence of severe intraoperative hypotension
Severe intraoperative hypotension is defined as MAP \< 55 mmHg
Time frame: From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.
Time from discontinuation of anesthetic drugs to awakening.
Awakening is defined as the first eye opening in response to a verbal command.
Time frame: From discontinuation of anesthetic drugs to awakening, assessed up to 2 hours postoperatively.
the rate of postoperative delirium
Postoperative delirium is assessed using the Chinese version of the 3D-CAM scale. The Chinese version of the 3D-CAM has a sensitivity ranging from 84.6% to 87.2% and a specificity ranging from 96.7% to 97.4%. If a patient is admitted to the ICU, the CAM-ICU scale will be used to evaluate them for delirium.
Time frame: Postoperatively (4-6 hours), Day 1, Day 2, Day 3
Postoperative complications
The evaluation of postoperative complications will be conducted using Futier's classification system for postoperative complications, with the primary basis for assessment being medical record data and follow-up data.
Time frame: 30 days after the operation
All-cause mortality within 30 days after surgery.
All-cause mortality is defined as death from any cause occurring within 30 days following surgery.
Time frame: 30 days after operation
Hospital readmission within 30 days after surgery
Readmission is defined as any unplanned hospital admission occurring within 30 days after surgery.
Time frame: 30 days postoperatively.
The lowest MAP during anesthesia
The lowest MAP during anesthesia
Time frame: From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.
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