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

NCT06139692 | Completed Phase 4 DMC

• 1 other identifier: PEACE
• Study Type: interventional
• Target: 810
• Locations: 1 country
• Sites: 4

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 (8)

• Shift in the distribution of mRS scores 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

• RASS score ≤ -3 during procedure

  During operation

• Changes of the GCS score at 5-7 days

  5-7 days after randomization

Other Outcomes (10)

• Rates of symptomatic intracranial hemorrhage at 48 hours

  48 hours after randomization

• Rates of procedure-related complications

  within 90 days from randomization

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

  90 days after randomization

Study Arms (2)

the dexmedetomidine group

EXPERIMENTAL

For patients allocated to the DEX group, sedation will be induced with an intravenous loading dose of 1.0 μg/kg administered over 10 minutes, prepared from a standard 8 μg/mL solution. This will be immediately followed by a continuous maintenance infusion, delivered via pump at a rate ranging from 0.2 to 0.7 μg/kg/h, with adjustments made according to the desired clinical effect. If adequate sedation cannot be achieved with DEX alone, physicians or anesthesiologists are permitted to administer rescue sedation agents (such as propofol) or consider transitioning the patient to general anesthesia.

Drug: Dexmedetomidine

the midazolam group

ACTIVE COMPARATOR

For patients allocated to the MDZ group, sedation will be initiated with an intravenous bolus of 0.05 mg/kg, drawn from a standard 1 mg/mL solution. A continuous maintenance infusion will then be started at a rate between 0.04 and 0.2 mg/kg/h, titrated to effect using an infusion pump. The infusion rate can be adjusted based on the sedation effect to achieve the appropriate level of sedation during EVT. If MDZ does not achieve satisfactory sedation during procedure, physicians or anesthesiologists may choose rescue sedation agents (such as propofol) or consider transitioning the patient to general anesthesia.

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 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;
• Long-term use of sedative medications, α2-adrenergic receptor agonists (such as clonidine), or potent CYP450 inhibitors or inducers before randomization;
• Uncontrolled hypertension or hypotension (defined as systolic blood pressure \> 185 mmHg or \< 90 mmHg, diastolic blood pressure \> 110 mmHg or \< 60 mmHg) measured prior to randomization;
• 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\*10\^9/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 ≤ 1 year;
• Severe agitation or seizures;
• Clinical manifestations of central nervous system vasculitis;

Sponsors & Collaborators

• Jinling Hospital, China: lead

Study Sites (4)

Yijishan Hospital of Wannan Medical College

Wuhu, Anhui, 241001, China

Location

Jinling Hospital, Medical School of Nanjing University

Nanjing, None Selected, China

Location

Liaocheng Third hsopital

Liaocheng, Shandong, China

Location

The General Hospital of Western Theater Command PLA

Chengdu, China

Location

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

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: May 30, 2026
• Study Completion: July 1, 2026
• Last Updated: September 24, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)