RecruitingNot ApplicableNCT07328958

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

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


Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Enrollment

500 participants

Start Date

Jan 16, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 65 Years

Inclusion Criteria3

  • 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 Criteria9

  • 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 manipulation due to surgical factors
  • Anticipated blood loss \>15% of estimated blood volume
  • Expected surgical duration \<1 hours or \>6 hours
  • Expected postoperative hospital stay \<72 hours

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Interventions

DRUGtitrated anesthesia

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.


Locations(2)

Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

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NCT07328958


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