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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат titrated 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.

Первичные конечные точки

• Incidence of intraoperative hypotension. [Срок оценки: From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.]

Вторичные конечные точки (12)

• the time-weighted area under the curve (TWA) for MAP <65 mmHg during the anesthesia period [Срок оценки: 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; [Срок оценки: 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 [Срок оценки: From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.]
• Time to first hypotension [Срок оценки: From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.]
• CI trend during anesthesia [Срок оценки: From induction of general anesthesia to the beginning of surgery, assessed intraoperatively for up to 2 hours.]
• The time periods with a higher incidence of hypotension between the two groups [Срок оценки: 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 [Срок оценки: 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. [Срок оценки: From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.]
• The incidence of severe intraoperative hypotension [Срок оценки: 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. [Срок оценки: From discontinuation of anesthetic drugs to awakening, assessed up to 2 hours postoperatively.]
• the rate of postoperative delirium [Срок оценки: Postoperatively (4-6 hours), Day 1, Day 2, Day 3]
• Postoperative complications [Срок оценки: 30 days after the operation]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• Sixth Affiliated Hospital, Sun Yat-sen University — Гуанчжоу
• Sixth Affiliated Hospital, Sun Yat-sen University — Гуанчжоу

Публикации

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Идентификаторы

NCT: NCT07328958 · 2025ZSLYEC-415

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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