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

Comparison of Perioperative Conscious Sedation During Endovascular Thrombectomy in Acute Ischemic Stroke (PEACE) A Randomised Multicentre Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Midazolam

Detailed Description

In the perioperative period of endovascular thrombectomy, the main sedation options are midazolam (MDZ) and dexmedetomidine (DEX). Research has shown that both sedation methods have their advantages and disadvantages, and there is no consensus on how to choose between them. Therefore, 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 (EVT) in AIS patients with large vessel occlusion in the anterior circulation and hopes to contribute to the advancement of EVT in clinical practice.

In this trial, acute ischemic stroke patients with large vessel occlusion in the anterior circulation within 24 hours of symptom onset or last known well will be included. In the screening stage, participants who meet the inclusion criteria of the trial, upon completion of screening/baseline assessment and after signing the informed consent, will be randomly assigned in a 1:1 ratio to one of the following two treatment groups: the dexmedetomidine and midazolam conscious sedation groups. The primary end point is the proportion of modified Ranking score of 0-2 at 90 days.

• Study Type: Interventional
• Enrollment (Estimated): 810
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Rui Liu; Phone Number: +86 2584801861; Email: liurui8616@163.com
• Study Contact Backup: Name: Xinfeng Liu; Phone Number: +86 2584801861; Email: xfliu2@vip.163.com

Study Locations

• China
  • Chengdu, China
    • Recruiting
    • The General Hospital of Western Theater Command PLA
    • Contact: Yao Huang; Phone Number: +86-18608398843; Email: m15928868662@163.com
  • None Selected
    • Nanjing, None Selected, China
      • Recruiting
      • Jinling Hospital, Medical School of Nanjing University
      • Contact: Rui Liu; Phone Number: +862584801861; Email: liurui8616@163.com
      • Contact: Xinfeng Liu; Phone Number: +862584801861; Email: xfliu2@vip.163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥18 years
2. Presenting with symptoms of acute ischemic stroke
3. CTA or MRA confirmed occlusion of the anterior circulation (intracranial carotid artery or M1, M2 segment of the middle cerebral artery)
4. Randomization finished within 24 hours of symptom onset or time last know well
5. Pre-stroke mRS score ≤2
6. NIHSS score ≥6 at the time of randomization
7. ASPECTS value ≥3
8. Informed consent signed

Exclusion Criteria:

General exclusion criteria

1. Pregnant or lactating women
2. Known allergy to contrast agents or nitinol devices
3. Known allergy to midazolam or other benzodiazepines
4. Known allergy to dexmedetomidine or its components
5. Planned to receive general anesthesia for EVT
6. Uncontrolled hypertension or hypotension (defined as systolic blood pressure >185 mmHg or < 90 mmHg, diastolic blood pressure >110 mmHg or < 60 mmHg)
7. Second-degree or third-degree heart blockage or bradyarrhythmia with a baseline heart rate lower than 50 beats/min
8. Any major surgery or serious trauma within 14 days
9. Known genetic or acquired bleeding diathesis (platelet count < 100\*109 /L, activated partial thromboplastin time > 50 s or international normalized ratio > 1.7)
10. Blood glucose <2.8 or > 22.2 mmol/L
11. Severe renal insufficiency (defined as glomerular filtration rate <30 ml/min or serum creatinine >220 mmol/L (2.5mg/dl))
12. Receiving hemodialysis or peritoneal dialysis
13. Life expectancy less than 1 year
14. Severe agitation or seizures
15. Clinical manifestations of central nervous system vasculitis
16. Premorbid neurological disease or mental disorders confounding evaluation
17. Unwilling to be followed up within 90 days
18. Participation in other interventional randomized clinical trials Imaging exclusion criteria

1. Evidence of intracranial hemorrhage on CT or MRI 2. Cerebellar infarction with obvious space-occupying effects and fourth ventricle compression on CT or MRI 3. Any untreated or incompletely treated intracranial aneurysm or any intracranial vascular malformation 4. Bilateral occlusion or multiple intracranial vessels occlusions 5. Intracranial tumors (with mass effect)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: the dexmedetomidine group; 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; Patients receive perioperative sedation with dexmedetomidine
Active Comparator: the midazolam group; 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; Patients receive perioperative sedation with midazolam

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shift in the distribution of mRS scores 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
The proportion of mRS score 0-1 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
The proportion of mRS score 0-3 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
Rates of successful recanalization	Successful recanalization is defined as mTICI≥2b. mTICI is short for modified Thrombolysis in cerebral Infarction (ranging from 0 to 3, with higher values indicating a better reperfusion state).	Immediately after the thrombectomy procedure is completed
Changes of the GCS score at 24 hours	GCS is short for Glasgow Coma Scale. GCS is a score of the degree of comma (range from 3 to 15, higher values indicate more severe comma).	24 hours after randomization
Changes of the NIHSS score at 24 hours	NIHSS is short for National Institute of Health stroke scale. NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severe deficits).	24 hours after randomization
Changes of the GCS score at 5-7 days	GCS is short for Glasgow Coma Scale. GCS is a score of the degree of comma (range from 3 to 15, higher values indicate more severe comma).	5-7 days after randomization
Changes of the NIHSS score at 5-7 days	NIHSS is short for National Institute of Health stroke scale. NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severe deficits).	5-7 days after randomization
Barthel Index at 90 days	Barthel Index is an ordinal disability score of 10 categories (range from 0 to 100, higher values indicate better prognosis)	90 days after randomization
Score on the ASPECTS at 24-72 hours	ASPECTS is short for Alberta Stroke Program Early CT Score (ranging from 0 to 10, with a higher score indicating a better perfusion state).	24-72 hours after randomization
RASS score ≤ -3 during procedure	Deep sedation defined as RASS score ≤ -3. RASS is short for Richmond Agitation and Sedation Scale. RASS is a score of the degree of sedation (range from -5 to +4, higher values indicate a worse sedation state).	During operation
RASS score ≤ 0 during procedure	Under sedation defined as RASS score ≤ 0. RASS is short for Richmond Agitation and Sedation Scale. RASS is a score of the degree of sedation (range from -5 to +4, higher values indicate a worse sedation state).	During operation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of symptomatic intracranial hemorrhage at 48 hours	Clinical safety endpoint. Intracranial hemorrhage within 48 hours on CT/MRI according to Heidelberg bleeding classification.	48 hours after randomization
Rates of procedure-related complications	Clinical safety endpoint	within 90 days from randomization
Rates of mortality at 90 days	Clinical safety endpoint	within 90 days from randomization
Rates of adverse events	Clinical safety endpoint	within 90 days from randomization
Rates of severe adverse events	Clinical safety endpoint	with 90 days from randomization

Collaborators and Investigators

• Sponsor: Jinling Hospital, China
• Investigators: Principal Investigator: Xinfeng Liu, Department of Neurology, Jinling Hospital, China

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2023
• Primary Completion (Estimated): June 13, 2026
• Study Completion (Estimated): June 13, 2026

Study Registration Dates

• First Submitted: November 10, 2023
• First Submitted That Met QC Criteria: November 15, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 16, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Ischemic Stroke; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Azoles; Imidazoles; Benzazepines; Benzodiazepines; Midazolam; Dexmedetomidine
• Other Study ID Numbers: PEACE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No