Comparison of Perioperative Conscious Sedation During Endovascular Thrombectomy in Acute Ischemic Stroke

NCT06139692 | Recruiting Phase 4 DMC

• 1 other identifier: PEACE
• Study Type: interventional
• Target: 810
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims to conduct a multicenter, prospective, randomized clinical trial to scientifically evaluate the safety and efficacy of different perioperative sedation methods during endovascular thrombectomy in acute ischemic stroke patients with large vessel occlusion in the anterior circulation.

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• The proportion of mRS score 0-2 at 90 days

  mRS is short for modified Ranking score (ranging from 0 to 6, with higher values indicating a worse functional outcome).

  90 days after randomization

Secondary Outcomes (12)

• Shift in the distribution of mRS scores at 90 days

  90 days after randomization

• The proportion of mRS score 0-1 at 90 days

  90 days after randomization

• The proportion of mRS score 0-3 at 90 days

  90 days after randomization

• Rates of successful recanalization

  Immediately after the thrombectomy procedure is completed

• Score on the ASPECTS at 24-72 hours

  24-72 hours after randomization

Other Outcomes (5)

• Rates of symptomatic intracranial hemorrhage at 48 hours

  48 hours after randomization

• Rates of procedure-related complications

  within 90 days from randomization

• Rates of mortality at 90 days

  within 90 days from randomization

Study Arms (2)

the dexmedetomidine group

EXPERIMENTAL

In the experimental group, dexmedetomidine is used for intraoperative sedation. Dexmedetomidine is prepared as an 8μg/ml intravenous infusion. It begins with an initial loading dose of 1μg/kg, administered over a period exceeding 10 minutes.If dexmedetomidine fails to achieve a satisfactory level of sedation during surgery, physicians may opt for rescue sedation with propofol or consider transferring the patient to general anesthesia. Propofol (20ml 0.2g) starts with a loading dose of 0.3mg/(kg\*h) and a maintenance dose of 0.3-4mg/(kg\*h). The infusion rate can be adjusted based on the sedation effect to achieve the appropriate level of sedation during EVT.

Drug: Dexmedetomidine

the midazolam group

ACTIVE COMPARATOR

In the control group, midazolam is used for intraoperative sedation. Midazolam is prepared as a 1mg/ml intravenous infusion. It starts with an initial intravenous push of 0.05mg/kg, followed by a maintenance dose of 0.04-0.2mg/kg administered intravenously via an infusion pump. If midazolam fails to achieve a satisfactory level of sedation during surgery, physicians may opt for rescue sedation with propofol or consider transferring the patient to general anesthesia. Propofol (20ml 0.2g) starts with a loading dose of 0.3mg/(kg\*h) and a maintenance dose of 0.3-4mg/(kg\*h). The infusion rate can be adjusted based on the sedation effect to achieve the appropriate level of sedation during EVT.

Drug: Midazolam

Interventions

Dexmedetomidine DRUG

Patients receive perioperative sedation with dexmedetomidine

the dexmedetomidine group

Midazolam DRUG

Patients receive perioperative sedation with midazolam

the midazolam group

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
• Presenting with symptoms of acute ischemic stroke
• CTA or MRA confirmed occlusion of the anterior circulation (intracranial carotid artery or M1, M2 segment of the middle cerebral artery)
• Randomization finished within 24 hours of symptom onset or time last know well
• Pre-stroke mRS score ≤2
• NIHSS score ≥6 at the time of randomization
• ASPECTS value ≥3
• Informed consent signed

You may not qualify if:

• Pregnant or lactating women
• Known allergy to contrast agents or nitinol devices
• Known allergy to midazolam or other benzodiazepines
• Known allergy to dexmedetomidine or its components
• Planned to receive general anesthesia for EVT
• Uncontrolled hypertension or hypotension (defined as systolic blood pressure \>185 mmHg or \< 90 mmHg, diastolic blood pressure \>110 mmHg or \< 60 mmHg)
• Second-degree or third-degree heart blockage or bradyarrhythmia with a baseline heart rate lower than 50 beats/min
• Any major surgery or serious trauma within 14 days
• Known genetic or acquired bleeding diathesis (platelet count \< 100\\\*109 /L, activated partial thromboplastin time \> 50 s or international normalized ratio \> 1.7)
• Blood glucose \<2.8 or \> 22.2 mmol/L
• Severe renal insufficiency (defined as glomerular filtration rate \<30 ml/min or serum creatinine \>220 mmol/L (2.5mg/dl))
• Receiving hemodialysis or peritoneal dialysis
• Life expectancy less than 1 year
• Severe agitation or seizures
• Clinical manifestations of central nervous system vasculitis

Sponsors & Collaborators

• Jinling Hospital, China: lead

Study Sites (2)

Jinling Hospital, Medical School of Nanjing University

Nanjing, None Selected, China

RECRUITING

The General Hospital of Western Theater Command PLA

Chengdu, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Dexmedetomidine; Midazolam

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Xinfeng Liu

  Department of Neurology, Jinling Hospital, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rui Liu

CONTACT

+86 2584801861; liurui8616@163.com

Xinfeng Liu

CONTACT

+86 2584801861; xfliu2@vip.163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: November 18, 2023
• Study Start: November 21, 2023
• Primary Completion (Estimated): June 13, 2026
• Study Completion (Estimated): June 13, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)