Effects of Post-operative Sedation on Clinical Outcomes in Patients Receiving Endovascular Thrombectomy for Acute Ischemic Stroke

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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

• have endovascular thrombectomy under GA and are confirmed to achieve successful reperfusion (mTICI 2b-3) by digital subtraction angiography (DSA) exam at the end of the operation.

• Informed consent by the patient him-/herself or his/her legal representative

Locations
Other Locations
China
Renji Hospital
RECRUITING
Shanghai
Contact Information
Primary
Weifeng Yu, Ph.D.
ywf808@yeah.net
86-21-68383702
Backup
Jie Tian, Ph.D.
vaseline2001@hotmail.com
86-21-68383702
Time Frame
Start Date: 2021-11-24
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 1286
Treatments
Experimental: POS group
Patients in the POS group will undergo ET under general anesthesia. After the surgery is done, patients will keep being intubated and mechanically ventilated for 6hrs, during which period the patients will be sedated with sedatives to maintain a BIS value of 50\~70 and Ramsay sedation score of 5 \~ 6. The SBP will be controlled between 120 \~ 180mmHg with vasoactive drugs. After 6hs, the patients will be recovered and extubated.
Active_comparator: Con group
Patients in the Con group will undergo ET under general anesthesia and will be routinely recovered and extubated immediately after the surgery is done. The SBP will be controlled between 120 \~ 180mmHg with vasoactive drugs for at least 7hrs after the surgery.
Related Therapeutic Areas
Sponsors
Collaborators: Second Affiliated Hospital, School of Medicine, Zhejiang University, Fujian Provincial Hospital, Tongji University, Shanghai 6th People's Hospital, The Affiliated Hospital of Ningbo University, Henan Provincial People's Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine, Beijing Chao Yang Hospital, Huashan Hospital, The First People's Hospital of Lianyungang, Changhai Hospital
Leads: RenJi Hospital

This content was sourced from clinicaltrials.gov