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Not yet recruiting NCT07696208

Ciprofol vs Propofol for Hemodynamic Stability in Patients Having General Anesthesia for Endovascular Thrombectomy After Ischemic Stroke

Phase IV Interventional Hemodynamic Stability Ischemic Strokes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ciprofol, Propofol.
Who it may be relevant to
Registry conditions: Hemodynamic Stability, Ischemic Strokes. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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)

Overview

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.

Detailed description

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.

Interventions

  • Drug Ciprofol
    Induction of anesthesia followed by continuous infusion through out surgery. Adjust infusion rate according to BIS (BIS target: 40-60). Adjust vasoactive/hypotensive drugs according to hemodynamics.
  • Drug Propofol
    Induction of anesthesia followed by continuous infusion through out surgery. Adjust infusion rate according to BIS (BIS target: 40-60). Adjust vasoactive/hypotensive drugs according to hemodynamics.

Primary outcome measures

  • Time-weighted average of SBP under the threshold of 120 mmHg after general anesthesia induction until end of surgery [Time frame: During operation]
Secondary outcome measures (10)
  • Cumulative time of SBP <120 mmHg [Time frame: During operation]
  • Cumulative time of SBP decreased by 20% from the baseline value [Time frame: During operation]
  • Norepinephrine equivalent [Time frame: During operation]
  • Cognitive function evaluated by 3days 3D-CAM and 90-day T-MoCA [Time frame: 3 days and 90 days after operation]
  • 90-day mRS score [Time frame: 90 days after operation]
  • 24h NIHSS, 24h NIHSS score 0-1 or or improvement more than 8 [Time frame: 24 hours after operation]
  • 24h recanalization status [Time frame: 24 hours after operation]
  • 48h infarct volume [Time frame: 48 hours after operation]
  • 90-day mortality [Time frame: 90 days after operation]
  • Safety Assessments [Time frame: 90 days after operation]

Eligibility criteria

Inclusion criteria

  • Age ≥18 years.
  • Clinical diagnosis of AIS.
  • CT/MRI-confirmed absence of intracranial hemorrhage.
  • Eligible for EVT.
  • NIHSS score ≥2.
  • ASA physical status I-III.
  • Signed informed consent.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Shanghai Jiaotong University School of Medicine — Shanghai

Identifiers

NCT: NCT07696208 · LY2025-432-A

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗