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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorRenJi Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years.

Clinical diagnosis of AIS.

CT/MRI-confirmed absence of intracranial hemorrhage.

Eligible for EVT.

Disqualifiers

Pre-existing severe neurological deficits (mRS 3-5).

Shock.

Severe cardiac disease.

Contraindications to EVT per AHA guidelines.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ciprofol

    Drug

    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.

  • Propofol

    Drug

    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.

Treatment groups

124 Participants
are divided into 2 treatment groups
Group A: CiprofolExperimental treatment 1 intervention
Group B: PropofolActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
During operation

Secondary outcomes

1

Cumulative time of SBP <120 mmHg

Represents the cumulative time of SBP under 120 mmHg over the operation time.

Time frame
During operation
2

Cumulative time of SBP decreased by 20% from the baseline value

Represents the cumulative time under the baseline SBP over the operation time.

Time frame
During operation
3

Norepinephrine equivalent

Norepinephrine, phenylephrine and epinephrine doses along with other vasopressor will be analyzed together during the entire procedure.

Time frame
During operation
4

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.

Time frame
3 days and 90 days after operation

Other outcomes

Sponsors and contacts

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RenJi Hospital

Lead sponsor

Haisco Pharmaceutical Group Co., Ltd.

Collaborator

This trial is not recruiting at the moment. You can still explore other options: