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

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)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ischemic Strokes; Hemodynamic Stability
• Intervention / Treatment: Drug: Ciprofol; Drug: Propofol

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.

• Study Type: Interventional
• Enrollment (Estimated): 124
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Lv Xie; Phone Number: 13585597926; Email: xielv6703@renji.com

Study Locations

• China
  • Pudong New Area
    • Shanghai, Pudong New Area, China
      • Shanghai Jiaotong University School of Medicine
      • Contact: Lv Xie; Phone Number: 13585597926; Email: xielv6703@renji.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ciprofol; For patients in the ciprofol group, ciprofol will be given as induction of anesthesia (0.2 mg/kg) followed by a continuous infusion (0.8 mg/kg/h) until the end of surgery.	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.
Active Comparator: Propofol; For patients in the propofol group, propofol will be given as induction of anesthesia (1 mg/kg) followed by a continuous infusion (4 mg/kg/h) until the end of surgery.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time-weighted average of SBP under the threshold of 120 mmHg after general anesthesia induction until end of surgery	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.	During operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative time of SBP <120 mmHg	Represents the cumulative time of SBP under 120 mmHg over the operation time.	During operation
Cumulative time of SBP decreased by 20% from the baseline value	Represents the cumulative time under the baseline SBP over the operation time.	During operation
Norepinephrine equivalent	Norepinephrine, phenylephrine and epinephrine doses along with other vasopressor will be analyzed together during the entire procedure.	During operation
Cognitive function evaluated by 3days 3D-CAM and 90-day T-MoCA	Delirium will be assessed in person twice daily during the initial three postoperative days using 3D-CAM or CAM-ICU when patients are intubated. Long-term cognitive function will be assessed by the telephone version of the Montreal Cognitive Assessment (T-MoCA) which is designed for telephone use and is also well-validated and well accepted. MoCA is a well-regarded cognitive assessment tool that has possible scores ranging from 0 to 30 points.	3 days and 90 days after operation
90-day mRS score	The mRS is the preferred disability parameter for clinical trials in stroke. The mRS is an ordinal hierarchical scale incorporating six categories from 0 up to and including 5, and describes the range of disability encountered post stroke. 'Death' is assigned a score of 6.	90 days after operation
24h NIHSS, 24h NIHSS score 0-1 or or improvement more than 8	Scores on the National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with higher scores indicating more severe neurologic deficits. NIHSS score 0-1 or ≥8 points reduction in NIHSS score from baseline indicate neurological function recovery and improvement.	24 hours after operation
24h recanalization status	Occurrence of TICI 2b or 3 recanalization on CTA or MRA. The thrombolysis in cerebral infarction (TICI) scale is a tool for determining the response of thrombolytic therapy for ischemic stroke. The original description was based on the angiographic appearances of the treated occluded vessel and the distal branches (Grade 0: no perfusion, Grade 1: penetration with minimal perfusion, Grade 2: partial perfusion, Grade 2A: only partial filling (less than two-thirds) of the entire vascular territory is visualized, Grade 2B: complete filling of all of the expected vascular territory is visualized but the filling is slower than normal, Grade 3: complete perfusion).	24 hours after operation
48h infarct volume	Infarct volume will be assessed with the use of an automated, validated algorithm. Infarct size at 48h will be compared with imaging examination results at baseline.	48 hours after operation
90-day mortality	The proportion of all patients who died in each group.	90 days after operation
Safety Assessments	Safety assessments will be conducted during the screening period, throughout the study, and after study completion. Investigators may perform additional safety evaluations during the treatment period as clinically indicated. Participants who discontinue the study early should undergo an end-of-study visit and safety assessment prior to withdrawal. During the trial, the following safety variables will be recorded regularly. Monitor frequency of adverse events, alterations in clinical safety parameters (changes in physical examination, oxygen saturation, systolic/diastolic blood pressure, pulse) and laboratory tests (Complete blood count, blood chemistry tests, coagulation function).	90 days after operation

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Collaborators: Haisco Pharmaceutical Group Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): May 31, 2028

Study Registration Dates

• First Submitted: July 6, 2026
• First Submitted That Met QC Criteria: July 6, 2026
• First Posted (Actual): July 10, 2026

Study Record Updates

• Last Update Posted (Actual): July 10, 2026
• Last Update Submitted That Met QC Criteria: July 6, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Propofol; Ischemic Stroke; Ciprofol; General Anesthesia; Hemodynamic Stability; Endovascular Thrombectomy
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Ischemic Stroke; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Phenols; Benzene Derivatives; Propofol; (2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol
• Other Study ID Numbers: LY2025-432-A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No