Effect of Titrated Administration of Ciprofol Combined With Remifentanil on Perioperative Hypotension in Elderly Patients Undergoing Laparoscopic Abdominal Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Incidence of intraoperative hypotension.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Data Analyst
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
controled group
Patients in this group will undergo anesthesia induction and maintenance with ciprofol and remifentanil. Induction will be performed with intravenous bolus administration of ciprofol at a dose of 0.4 mg/kg and remifentanil at a dose of 1.2μg/kg, followed by a neuromuscular blocker to facilitate tracheal intubation. During surgery, anesthetic doses will be adjusted at the discretion of the anesthesiologist, based on the patient's physiological parameters and surgical conditions. BIS monitoring is applied and the screen remains visible to the anesthesiologist. However, ciprofol dose adjustments are made according to routine clinical judgement without reference to a prespecified BIS target or structured titration rule.
titrated group
In this group, anesthesia induction is performed with continuous infusion of ciprofol until loss of consciousness (OAA/S score = 1). Remifentanil 1.2 μg/kg is then administered, followed by a neuromuscular blocker to facilitate tracheal intubation. After intubation, anesthesia was maintained with ciprofol (0.4-3 mg/kg/h) and remifentanil (0.01-0.5 µg/kg/min) until the end of surgery. Depth of anesthesia was adjusted intraoperatively to maintain BIS at approximately 50.
干预措施: titrated anesthesia (Drug)
结局指标
主要结局
Incidence of intraoperative hypotension.
时间窗: From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.
Hypotension is defined as at least one episode of mean arterial pressure (MAP) \<65 mmHg sustained for at least 1 minute.
次要结局
- CI trend during anesthesia(From induction of general anesthesia to the beginning of surgery, assessed intraoperatively for up to 2 hours.)
- the time-weighted area under the curve (TWA) for MAP <0.8 baseline during the anesthesia period(From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.)
- Time to first hypotension(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(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;(From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.)
- CI trend during anesthesia(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.(From discontinuation of anesthetic drugs to awakening, assessed up to 2 hours postoperatively.)
- The time periods with a higher incidence of hypotension between the two groups(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(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.(From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.)
- The incidence of severe intraoperative hypotension(From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.)
- the rate of postoperative delirium(Postoperatively (4-6 hours), Day 1, Day 2, Day 3)
- Postoperative complications(30 days after the operation)
- All-cause mortality within 30 days after surgery.(30 days after operation)
- Hospital readmission within 30 days after surgery(30 days postoperatively.)
- The lowest MAP during anesthesia(From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.)
研究者
SanQing Jin
professor
Sixth Affiliated Hospital, Sun Yat-sen University