Status:

ACTIVE_NOT_RECRUITING

The Effect of Sedoanalgesia and General Anaesthesia on Early Neurological Recovery in Acute Ischaemic Stroke Patients Undergoing Endovascular Thrombectomy

Lead Sponsor:

Umraniye Education and Research Hospital

Conditions:

Ischemic Stroke

Anesthesia

Eligibility:

All Genders

18-80 years

Phase:

NA

Brief Summary

The hypothesis of this study is that sedoanalgesia will provide better early neurological recovery than general anaesthesia in acute ischaemic stroke patients undergoing endovascular thrombectomy and ...

Detailed Description

Endovascular mechanical thrombectomy (EMT) is the standard emergency treatment for patients presenting with acute ischemic stroke in the anterior circulation due to urgent large vessel occlusion and s...

Eligibility Criteria

Inclusion

  • Presence of cerebral ischemic embolism within the first 6 hours
  • ASA 1-4
  • Body mass index below 30 kg m-2
  • NIHSS score ≥ 10
  • Presence of isolated/combined occlusion at any level of the anterior circulation internal carotid or middle cerebral artery

Exclusion

  • Chronic renal failure
  • EF less than 40
  • Presence of intracranial hemorrhage
  • Previous known history of severe neurological disease
  • Presence of bleeding diathesis
  • Pre-procedure GCS ≤ 8 and intubated patients
  • Failure to clearly show the site of vascular occlusion on diagnostic imaging results
  • Clinical or imaging evidence of vascular occlusion that is not internal carotid artery or middle cerebral artery
  • Absence of gag reflex, loss of airway protective reflex, inadequate saliva swallowing
  • History of lung infection, advanced COPD or respiratory failure
  • Known history of aspiration due to vomiting,
  • Known history of difficult airway
  • In the presence of known intolerance or allergy to certain drugs for sedation, analgesia or both
  • Previously known carotid artery stenosis
  • Pregnant patients
  • Patients without consent

Key Trial Info

Start Date :

November 30 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

July 30 2026

Estimated Enrollment :

62 Patients enrolled

Trial Details

Trial ID

NCT06183567

Start Date

November 30 2023

End Date

July 30 2026

Last Update

November 19 2025

Active Locations (1)

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Umraniye Education and Research Hospital

Istanbul, Umraniye, Turkey (Türkiye), 34734