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

Sponsor

Jinling Hospital, China (Other)

Overall Status

Recruiting

CT.gov ID

NCT06139692

Collaborator

(none)

810

Enrollment

Locations

Arms

26.8

Anticipated Duration (Months)

405

Patients Per Site

15.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Ischemic Stroke	Drug: Dexmedetomidine Drug: Midazolam	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

810 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 21, 2023

Anticipated Primary Completion Date :

Nov 13, 2025

Anticipated Study Completion Date :

Feb 13, 2026

Arms and Interventions

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.	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.	Drug: Midazolam Patients receive perioperative sedation with midazolam

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.

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.

Drug: Midazolam

Patients receive perioperative sedation with midazolam

Outcome Measures

Primary Outcome Measures

The proportion of mRS score 0-2 at 90 days [90 days after randomization]
mRS is short for modified Ranking score (ranging from 0 to 6, with higher values indicating a worse functional outcome).

Secondary Outcome Measures

Shift in the distribution of mRS scores at 90 days [90 days after randomization]
mRS is short for modified Ranking score (ranging from 0 to 6, with higher values indicating a worse functional outcome).
The proportion of mRS score 0-1 at 90 days [90 days after randomization]
mRS is short for modified Ranking score (ranging from 0 to 6, with higher values indicating a worse functional outcome).
The proportion of mRS score 0-3 at 90 days [90 days after randomization]
mRS is short for modified Ranking score (ranging from 0 to 6, with higher values indicating a worse functional outcome).
Rates of successful recanalization [Immediately after the thrombectomy procedure is completed]
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).
Changes of ASPECTS score at 24-72 hours [24-72 hours after randomization]
ASPECTS is short for Alberta Stroke Program Early CT Score (ranging from 0 to 10, with a higher score indicating a better perfusion state).
Recanalization rate on CTA/MRA at 24-72 hours [24-72 hours after randomization]
Recanalization is defined as mTICI≥2b assessed with CTA/MRA. mTICI is short for modified Thrombolysis in cerebral Infarction (ranging from 0 to 3, with higher values indicating a better reperfusion state).
The infarct volume on 24-72 hours follow-up imaging [24-72 hours after randomization]
Infarct volume is evaluated by brain CT/MRI
RASS score between -3 and -1 during procedure [During operation]
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).
Changes of the GCS score at 24 hours [24 hours after randomization]
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).
Changes of the NIHSS score at 24 hours [24 hours after randomization]
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).
Changes of the GCS score at 5-7 days [5-7 days after randomization]
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).
Changes of the NIHSS score at 5-7 days [5-7 days after randomization]
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).
EQ-5D at 90 days [90 days after randomization]
EQ-5D is short for EuroQol Five Dimensions Questionnaire. EQ-5D is a five-dimension score (higher values indicate a worse prognosis).
Barthel Index at 90 days [90 days after randomization]
Barthel Index is an ordinal disability score of 10 categories (range from 0 to 100, higher values indicate better prognosis)

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

General exclusion criteria

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
Premorbid neurological disease or mental disorders confounding evaluation
Unwilling to be followed up within 90 days
Participation in other interventional randomized clinical trials Imaging exclusion criteria
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)