Effect of Ciprofol on Intraoperative Hypotension in Elderly Patients Receiving Renin-angiotensin System Inhibitors

Официальное название

The Effect of Ciprofol on Intraoperative Hypotension in Elderly Patients Receiving Renin-angiotensin System Inhibitors: a Prospective, Randomized Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Ciprofol group
  General anesthesia induction and maintenance were performed using ciprofol.
• Препарат Propofol group
  General anesthesia induction and maintenance were performed using propofol.

Первичные конечные точки

• The time-weighted average of hypotension [Срок оценки: From the beginning to the end of the surgery]

Вторичные конечные точки (12)

• Time-weighted average of hypotension [Срок оценки: within 15 minutes after induction of anesthesia]
• Incidence of intraoperative hypotension [Срок оценки: From the beginning to the end of the surgery]
• Dosage of vasoactive drugs [Срок оценки: From the beginning to the end of the surgery]
• Success rate of general anesthesia induction [Срок оценки: From the beginning to the end of the surgery]
• Proportion of intraoperative time with BIS ≤ 60 [Срок оценки: From the beginning to the end of the surgery]
• Total dosage of ciprofol and propofol [Срок оценки: From the beginning to the end of the surgery]
• Total dosage of rescue drugs [Срок оценки: From start of drug administration to MOAA/S ≤1 (up to 5 minutes)]
• Time to extubation [Срок оценки: Perioperative]
• Incidence of intraoperative adverse events [Срок оценки: From the beginning to the end of the surgery]
• Incidence of adverse events in the PACU [Срок оценки: during the PACU stay]
• Incidence of perioperative major adverse cardiovascular and cerebrovascular events [Срок оценки: Periprocedural]
• Changes in Stroke Volume Variation (SVV) [Срок оценки: Intraoperative]

Критерии участия

Критерии включения

• Patients undergoing elective abdominal surgery under general anesthesia
• Duration of surgery exceeding 2 hours
• Patients receiving long-term renin-angiotensin system inhibitor therapy (>3 months prior to surgery)
• Age ≥ 65 years
• ASA classification II-III
• Informed consent was obtained from patients or their guardians

Критерии исключения

• History of allergy to opioids, propofol, or ciprofol components.
• Anticipated difficult airway (limited mouth opening, restricted neck movement, or modified Mallampati grade III-IV) or difficult mask ventilation.

Body mass index ≤18 or ≥35 kg/m².

• Severe hepatic dysfunction (total bilirubin ≥3.0 mg/dL or AST/ALT ≥2 times the upper limit of normal).
• Severe renal impairment (creatinine clearance ≤30 mL/min).
• Cardiac diseases (AV block higher than first-degree, heart rate <50 bpm, severe arrhythmias, severe valvular heart disease, heart failure, or unstable angina on the day of surgery).
• Preoperative cognitive impairment, cerebrovascular disease, or history of psychiatric illness.
• Abnormal thyroid-stimulating hormone levels or history of thyroid replacement therapy.
• Unstable asthma or history of asthma.
• Alcohol abuse, drug abuse, chronic opioid dependence, or analgesic use exceeding 3 months.
• Lactating or pregnant women.

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

Тройное слепое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• The Second Affiliated Hospital of Zhejiang University anesthesiology department — Ханчжоу

Идентификаторы

NCT: NCT06952608 · 2025-0279

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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