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临床试验/NCT07696208
NCT07696208尚未招募4 期

Ciprofol vs Propofol for Hemodynamic Stability in Patients Having General Anesthesia for Endovascular Thrombectomy After Ischemic Stroke: A Multicenter Randomized Open-label Parallel-group Trial (CONSTANCY)

RenJi Hospital1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2026年7月1日最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
尚未招募
入组人数
124
试验地点
1
主要终点
Time-weighted average of SBP under the threshold of 120 mmHg after general anesthesia induction until end of surgery

研究概览

简要总结

Endovascular therapy (EVT) improves the prognosis of patients with acute ischemic stroke (AIS). EVT has been established as a standard of care for AIS caused with large vessel occlusion based on numerous randomized controlled trials. However, despite extensive attention to post-EVT blood pressure management as a potentially modifiable factor, the ability to achieve high reperfusion rates does not consistently translate into functional independence for a substantial number of patients. Thus, the focus has turned to the intra-procedural period, where blood pressure management may play a critical but underexamined role in determining functional outcomes independent of post-EVT care.

Guideline recommendation to maintain the blood pressure lowered to 185/110 mmHg before the EVT procedure in patients who have not received intravenous thrombolysis therapy. However, studies of blood pressure before reperfusion in this patient group have produced conflicting results. Thus, although randomized trials evaluating pre-thrombectomy blood pressure targets are yet unavailable, accumulating evidence suggests that active blood pressure lowering before reperfusion may be harmful, which underscores the importance of maintaining hemodynamic stability during the EVT procedure.

In this context, anesthetic management is a key determinant of intraprocedural blood pressure control. Propofol is the most commonly used general anesthetic during EVT surgery. However, propofol is a powerful venodilator and often provokes hypotension which may be especially detrimental in AIS patients. Ciprofol, a novel anesthetic/sedative, has been proven to possess excellent efficacy and safety which provides definitive general anesthesia/sedation while minimizing respiratory and hemodynamic depression. Before and during EVT, patients with hemodynamic stability may have better outcomes. Using ciprofol as the anesthesia agent may reduce the incidence and severity of hemodynamic instability during EVT. Therefore, it is of significant research value to investigate whether the use of ciprofol for general anesthesia is beneficial in AIS patients undergoing EVT.

详细描述

Endovascular therapy (EVT) improves the prognosis of patients with acute ischemic stroke (AIS). EVT has been established as a standard of care for AIS caused with large vessel occlusion based on numerous randomized controlled trials. However, despite extensive attention to post-EVT blood pressure management as a potentially modifiable factor, the ability to achieve high reperfusion rates does not consistently translate into functional independence for a substantial number of patients. Consequently, post-EVT intensive blood pressure lowering has not been recommended. In fact, the ischemic brain prior to reperfusion may be more vulnerable to blood pressure fluctuations due to disrupted microvascular integrity and impaired autoregulation. Thus, the focus has turned to the intra-procedural period, where blood pressure management may play a critical but underexamined role in determining functional outcomes independent of post-EVT care.

Guideline recommendation to maintain the blood pressure lowered to 185/110 mmHg before the EVT procedure in patients who have not received intravenous thrombolysis therapy is based on expert opinion. However, studies of blood pressure before reperfusion in this patient group have produced conflicting results. Multicenter Randomized Controlled Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands (MR CLEAN) registry showed an increase in systolic blood pressure above 150 mmHg before EVT was associated with poor functional outcome and mortality at 90 days, whereas individual patient data meta-analysis found that admission SBP ≥140 mmHg was associated with worse functional outcome, but no such association was observed for SBP <140 mmHg. Furthermore, subgroup analyses of two randomized controlled trials consistently showed that intensive blood pressure lowering before reperfusion was associated with worse functional outcomes. Thus, although randomized trials evaluating pre-thrombectomy blood pressure targets are yet unavailable, accumulating evidence suggests that active blood pressure lowering before reperfusion may be harmful, which underscores the importance of maintaining hemodynamic stability during the EVT procedure.

In this context, anesthetic management is a key determinant of intraprocedural blood pressure control. Propofol is the most commonly used general anesthetic during EVT surgery. However, propofol is a powerful venodilator and often provokes hypotension which may be especially detrimental in AIS patients. Ciprofol, a novel anesthetic/sedative, has been proven to possess excellent efficacy and safety which provides definitive general anesthesia/sedation while minimizing respiratory and hemodynamic depression. Before and during EVT, patients with hemodynamic stability may have better outcomes. Using ciprofol as the anesthesia agent may reduce the incidence and severity of hemodynamic instability during EVT. Therefore, it is of significant research value to investigate whether the use of ciprofol for general anesthesia is beneficial in AIS patients undergoing EVT.

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)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥18 years.
  • Clinical diagnosis of AIS.
  • CT/MRI-confirmed absence of intracranial hemorrhage.
  • Eligible for EVT.
  • NIHSS score ≥
  • ASA physical status I-III.
  • Signed informed consent.

排除标准

  • Pre-existing severe neurological deficits (mRS 3-5).
  • Severe cardiac disease.
  • Contraindications to EVT per AHA guidelines.
  • Participation in conflicting clinical trials.

结局指标

主要结局

Time-weighted average of SBP under the threshold of 120 mmHg after general anesthesia induction until end of surgery

时间窗: During operation

Time-weighted average (TWA) is a calculation of the depth (in mmHg) of hypotension below the 'threshold' SBP of 120 mmHg\*the time spent in hypotension in minutes, this results in an 'area'. To better compare this value between different operations the 'area' can be divided by the total duration of the operation. TWA= (depth hypotension below the 'threshold' in mmHg\*time spent in hypotension in minutes)/ total duration operation in minutes.

次要结局

  • Cumulative time of SBP decreased by 20% from the baseline value(During operation)
  • Norepinephrine equivalent(During operation)
  • Cumulative time of SBP <120 mmHg(During operation)
  • Cognitive function evaluated by 3days 3D-CAM and 90-day T-MoCA(3 days and 90 days after operation)
  • 90-day mRS score(90 days after operation)
  • 24h NIHSS, 24h NIHSS score 0-1 or or improvement more than 8(24 hours after operation)
  • 24h recanalization status(24 hours after operation)
  • 48h infarct volume(48 hours after operation)
  • 90-day mortality(90 days after operation)
  • Safety Assessments(90 days after operation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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