Effects of Post-Operative Sedation for Endovascular Thrombectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorRenJi Hospital
About this trial
Studies from our lab indicated that long-term sedation is protective in mice with midbrain infarct. To assess whether post-operative sedation has protective effects on clinical outcomes in patients with ischemic stroke undergoing endovascular thrombectomy (ET), a multi-center, randomized clinical trial will be carried out (POSET study). In POSET study, patients receiving ET for acute ischemic stroke under general anesthesia will be randomly assigned to the control group (Con group) and the post-operative sedation group (POS group). Patients in the Con group will be recovered and extubated immediately after the surgery, whereas those in the POS group will be sedated with propofol and dexmedetomidine for another 6hrs before extubation. The primary endpoint is the score on the modified Rankin Scale assessed at 90±7 days after randomization. The hypothesis is that patients in the POS group will have improved clinical outcome in 3 months after surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
are between 18 and 85 years old
have a clinical diagnosis of AIS due to anterior circulation large artery occlusion (including internal carotid artery or/and middle cerebral artery)
with a score on the National Institute of Health Stroke Scale (NIHSS) ≥10 before surgery
with a modified Rankin scale (mRS) <3 before stroke
Disqualifiers
previous intracranial hemorrhage within 6 weeks
vascular stents implantation in the responsible blood vessel
Glasgow score ≤8 points before surgery
known allergy to heparin, aspirin, clopidogrel, rapamycin, lactic acid polymer, stainless steel, and allergy or contraindication to contrast agent
Trial design
Design model
Parallel
Treatments tested in this trial
post-operative sedation
Procedure/SurgeryPatients with ischemic stroke will undergo endovascular thrombectomy (ET) under general anesthesia. After the ET surgery is done, patients in POS group will be sedated for 6hrs before extubation.
routine recovery
Procedure/SurgeryPatients with ischemic stroke will undergo endovascular thrombectomy (ET) under general anesthesia. Patients in Con group will be routinely recovered and extubated after the ET surgery is done.
Treatment groups
1,286 Participants
are divided into 2 treatment groupsGroup A: POS groupExperimental treatment 1 intervention
Group B: Con groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
the score on the modified Rankin Scale assessed at 90±7 days after randomization
The Modified Rankin Scale (mRS) assesses disability in patients who have suffered a stroke and is compared over time to check for recovery and degree of continued disability. A score of 0 is no disability, 5 is disability requiring constant care for all needs; 6 is death.
Time frame
at 90±7 days after ET surgerySecondary outcomes
1
Change in NIHSS score between admission and 24±6 hrs post-operation (NIHSSadmission-NIHSS24h)
The NIHSS classifies neurological deficit on a scale from 0 (no deficit) to 42 (most severe deficit).
Time frame
pre-operatively and at 24±6 hours after ET surgery2
Change in NIHSS score between admission and 5~7d post-operation (NIHSSadmission-NIHSS7d)
The NIHSS classifies neurological deficit on a scale from 0 (no deficit) to 42 (most severe deficit).
Time frame
pre-operatively and at 5~7 days after ET surgery3
Final infarct volume determined by DWI or CTP at 5~7d post-operation or at discharge
The infarct size will be detected by DWI or CTP
Time frame
at 5~7 days post-operation or at discharge4
The incidence of extubation delay
Extubation delay is defined as more than 1h is needed from the time all sedative medication is stopped and recovery is started to successful extubation.
Time frame
at 24 hours after ET surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
RenJi Hospital
Lead sponsor
Changhai Hospital
Collaborator
Huashan Hospital
Collaborator
Shanghai Tongji Hospital, Tongji University School of Medicine
Collaborator
Beijing Chao Yang Hospital
Collaborator
Shanghai 6th People's Hospital
Collaborator
Tongji University
Collaborator
Henan Provincial People's Hospital
Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborator
Fujian Provincial Hospital
Collaborator
The First People's Hospital of Lianyungang
Collaborator
The Affiliated Hospital of Ningbo University
Collaborator
Source ClinicalTrials.gov