Effects of Post-Operative Sedation for Endovascular Thrombectomy

NCT04517383 | Recruiting DMC

• 1 other identifier: POSET202008
• Study Type: interventional
• Target: 1,286
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Ischemic Stroke; Endovascular Thrombectomy

Outcome Measures

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.

  at 90±7 days after ET surgery

Secondary Outcomes (7)

• Change in NIHSS score between admission and 24±6 hrs post-operation (NIHSSadmission-NIHSS24h)

  pre-operatively and at 24±6 hours after ET surgery

• Change in NIHSS score between admission and 5~7d post-operation (NIHSSadmission-NIHSS7d)

  pre-operatively and at 5~7 days after ET surgery

• Final infarct volume determined by DWI or CTP at 5~7d post-operation or at discharge

  at 5~7 days post-operation or at discharge

• The incidence of extubation delay

  at 24 hours after ET surgery

• The incidence of extubation failure

  at 24 hours after ET surgery

Study Arms (2)

POS group

EXPERIMENTAL

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.

Procedure: post-operative sedation

Con group

ACTIVE COMPARATOR

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.

Procedure: routine recovery

Interventions

post-operative sedation PROCEDURE

Patients 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.

POS group

routine recovery PROCEDURE

Patients 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.

Con group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• contraindication to dexmedetomidine
• known hemoglobin less than 70g/L, platelet count less than 50×109L, international normalized ratio (INR) greater than 1.5, or other uncorrectable bleeding issues
• severe liver or kidney dysfunction, i.e. ALT or AST \>3 times the upper limit of normal, or creatinine \>1.5 times the upper limit of normal
• are pregnant or breast feeding
• have history of mental illness
• are currently participating in another clinical trial.

Sponsors & Collaborators

• RenJi Hospital: lead
• 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

Study Sites (1)

Renji Hospital

Shanghai, 200126, China

RECRUITING

Related Publications (2)

• Simonsen CZ, Yoo AJ, Sorensen LH, Juul N, Johnsen SP, Andersen G, Rasmussen M. Effect of General Anesthesia and Conscious Sedation During Endovascular Therapy on Infarct Growth and Clinical Outcomes in Acute Ischemic Stroke: A Randomized Clinical Trial. JAMA Neurol. 2018 Apr 1;75(4):470-477. doi: 10.1001/jamaneurol.2017.4474.

  PMID: 29340574 BACKGROUND

• Tosello R, Riera R, Tosello G, Clezar CN, Amorim JE, Vasconcelos V, Joao BB, Flumignan RL. Type of anaesthesia for acute ischaemic stroke endovascular treatment. Cochrane Database Syst Rev. 2022 Jul 20;7(7):CD013690. doi: 10.1002/14651858.CD013690.pub2.

  PMID: 35857365 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Weifeng Yu, Ph.D.

CONTACT

86-21-68383702; ywf808@yeah.net

Jie Tian, Ph.D.

CONTACT

86-21-68383702; vaseline2001@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2020
• First Posted: August 18, 2020
• Study Start: November 24, 2021
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)