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

Acute Ischemic Stroke Clinical Trial

— PEACE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06139692
• Other study ID #: PEACE
• Status: Recruiting
• Phase: Phase 4
• Start date: November 21, 2023
• Est. completion date: February 13, 2026

Study information

• Verified date: February 2024
• Source: Jinling Hospital, China
• Contact: Rui Liu
• Phone: +86 2584801861
• Email: liurui8616[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 810
• Est. completion date: February 13, 2026
• Est. primary completion date: November 13, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• Dexmedetomidine
Patients receive perioperative sedation with dexmedetomidine
• Midazolam
Patients receive perioperative sedation with midazolam

Locations

Country	Name	City	State
China	The General Hospital of Western Theater Command PLA	Chengdu
China	Jinling Hospital, Medical School of Nanjing University	Nanjing	None Selected

Sponsors (1)

Lead Sponsor	Collaborator
Jinling Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Rates of procedure-related complications	Clinical safety endpoint	within 90 days from randomization
Other	Rates of mortality at 90 days	Clinical safety endpoint	within 90 days from randomization
Other	Rates of adverse events	Clinical safety endpoint	within 90 days from randomization
Other	Rates of severe adverse events	Clinical safety endpoint	with 90 days from randomization
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Changes of ASPECTS score 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
Secondary	Recanalization rate on CTA/MRA at 24-72 hours	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).	24-72 hours after randomization
Secondary	The infarct volume on 24-72 hours follow-up imaging	Infarct volume is evaluated by brain CT/MRI	24-72 hours after randomization
Secondary	RASS score between -3 and -1 during procedure	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	EQ-5D at 90 days	EQ-5D is short for EuroQol Five Dimensions Questionnaire. EQ-5D is a five-dimension score (higher values indicate a worse prognosis).	90 days after randomization
Secondary	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