Hemodynamic StabilityPhase 4NCT07696208
Ciprofol vs Propofol for Hemodynamic Stability in Patients Having General Anesthesia for Endovascular Thrombectomy After Ischemic Stroke
A Phase 4 study testing Ciprofol and Propofol in people with Hemodynamic Stability and Ischemic Strokes, run by RenJi Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodynamic Stability, Ischemic Strokes
- What is being tested?
- Ciprofol and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2026to 31 May 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pre-existing severe neurological deficits (mRS 3-5).
- Shock.
- Severe cardiac disease.
- Contraindications to EVT per AHA guidelines.
- Participation in conflicting clinical trials.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Jiaotong University School of Medicine
Shanghai, Pudong New Area
Lv Xie, 13585597926, xielv6703@renji.com
About this study
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)
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.
Read the 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.
- Conditions
- Hemodynamic Stability, Ischemic Strokes
- Being tested
- Ciprofol, Propofol
- Keywords
- Ciprofol, Propofol, Hemodynamic Stability, General Anesthesia, Endovascular Thrombectomy, Ischemic Stroke
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiprofolDrug
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.
PropofolDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Ciprofol | Experimental | 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. Receives: Drug: Ciprofol |
| Propofol | Active comparator | 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. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During operation
Secondary outcomes (10)
Cumulative time of SBP <120 mmHg
Represents the cumulative time of SBP under 120 mmHg over the operation time.
Measured: 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.
Measured: During operation
Norepinephrine equivalent
Norepinephrine, phenylephrine and epinephrine doses along with other vasopressor will be analyzed together during the entire procedure.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 48 hours after operation
90-day mortality
The proportion of all patients who died in each group.
Measured: 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).
Measured: 90 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 Jan 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic StabilityStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Haisco Pharmaceutical Group Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07696208
- Sponsor's protocol ID
- LY2025-432-A
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07696208
- Acronym / sponsor ID
- LY2025-432-A
- Conditions
- Hemodynamic Stability, Ischemic Strokes
- Keywords
- Ciprofol, Propofol, Hemodynamic Stability, General Anesthesia, Endovascular Thrombectomy, Ischemic Stroke
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Haisco Pharmaceutical Group Co., Ltd.
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 10 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ciprofol | Experimental | Drug: CiprofolFor 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. |
| Propofol | Active comparator | Drug: PropofolFor 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years.
- Clinical diagnosis of AIS.
- CT/MRI-confirmed absence of intracranial hemorrhage.
- Eligible for EVT.
- NIHSS score ≥2.
Key exclusion criteria (5 listed)
- Pre-existing severe neurological deficits (mRS 3-5).
- Shock.
- Severe cardiac disease.
- Contraindications to EVT per AHA guidelines.
- Participation in conflicting clinical trials.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CiprofolInduction 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 | Ciprofol |
| PropofolInduction 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 |
Primary outcome
Time-weighted average of SBP under the threshold of 120 mmHg after general anesthesia induction until end of surgery
Time frame: 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.
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ciprofol and Propofol in people with Hemodynamic Stability and Ischemic Strokes, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lv Xie (13585597926, xielv6703@renji.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-weighted average of SBP under the threshold of 120 mmHg after general anesthesia induction until end of surgery (time frame: During operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.