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

NCT07696208 | Not Yet Recruiting Phase 4

• 1 other identifier: LY2025-432-A
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Hemodynamic Stability; Ischemic Strokes

Keywords

Ciprofol; Propofol; Hemodynamic Stability; General Anesthesia; Endovascular Thrombectomy; Ischemic Stroke

Outcome Measures

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.

  During operation

Secondary Outcomes (10)

• Cumulative time of SBP <120 mmHg

  During operation

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

  During operation

• Norepinephrine equivalent

  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

Study Arms (2)

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.

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.

Drug: Propofol

Interventions

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.

Ciprofol

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.

Propofol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• RenJi Hospital: lead
• Haisco Pharmaceutical Group Co., Ltd.: collaborator

Study Sites (1)

Shanghai Jiaotong University School of Medicine

Shanghai, Pudong New Area, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

(2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol; Propofol

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Lv Xie

CONTACT

13585597926; xielv6703@renji.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 10, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: July 10, 2026

Record last verified: 2026-07

Locations

CN (1)