Comparison of Perioperative Conscious Sedation During Endovascular Thrombectomy in Acute Ischemic Stroke (PEACE) a Randomised Multicentre Trial
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
The General Hospital of Western Theater Command PLA
RECRUITING
Chengdu
Jinling Hospital, Medical School of Nanjing University
RECRUITING
Nanjing
Contact Information
Primary
Rui Liu
liurui8616@163.com
+86 2584801861
Backup
Xinfeng Liu
xfliu2@vip.163.com
+86 2584801861
Time Frame
Start Date: 2023-11-21
Estimated Completion Date: 2026-02-13
Participants
Target number of participants: 810
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Jinling Hospital, China