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Recruiting NCT07328958

Effect of Titrated Administration of Ciprofol on Perioperative Hypotension in Elderly Patients Undergoing Laparoscopic Abdominal Surgery: A Randomized Controlled Trial

Trial Parameters

Condition Hypotension During Surgery
Sponsor Sixth Affiliated Hospital, Sun Yat-sen University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 500
Sex ALL
Min Age 65 Years
Max Age N/A
Start Date 2026-01-16
Completion 2026-12-30
Interventions
titrated anesthesia

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * Age ≥65 years, scheduled for elective laparoscopic abdominal surgery * American Society of Anesthesiologists (ASA) physical status I-III * Requirement for invasive arterial blood pressure monitoring Exclusion Criteria: * Participation in other clinical trials that may interfere with the intervention or outcomes of this study * Severe hepatic or renal disease (GFR ≤30 mL/min/1.73 m², requirement for renal replacement therapy, or Child-Pugh class C liver function) * Uncontrolled severe hypertension (preoperative SBP ≥180 mmHg or DBP ≥110 mmHg) * Patients with severe mental disorders (such as schizophrenia), epilepsy, or Parkinson's disease, severe cognitive or intellectual impairment, severe visual or hearing impairments affecting assessment, or long-term alcohol abuse or use of sedative/analgesic medications; * Known allergy to drugs used in this study * Requirement for continuous vasopressor infusion before surgery, or intraoperative need for prolonged hemodynamic

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