Study name |
Anaesthesiological care for thrombectomy in stroke |
Methods |
Setting: multicentre, Germany Design: RCT, 2 arms, parallel assignment, blind Start date: 6 April 2021 |
Participants |
868 men and women aged ≥ 18 years Inclusion criteria
Exclusion criteria
Mandatory GA or endotracheal intubation (e.g. due to airway obstruction that cannot be controlled with naso‐ or oropharyngeal tubes, vomiting with risk of tracheobronchial aspiration, severe agitation corresponding to Richmond Agitation Sedation Scale +3 or +4)
Suspected difficult airway
Haemodynamic instability (present or expected)
Mild neurological deficit (NIHSS < 5)
Prestroke mRS ≥ 3
In‐hospital onset of stroke
Isolated extracranial arterial occlusion
Suspected procedural technical difficulties while reaching the target occlusion
Inclusion in another interventional study
Age < 18 years
|
Interventions |
Experimental: GA Comparator: sedation anaesthesia |
Outcomes |
Primary outcome
Secondary outcome
Functional outcome at 30 and 90 days using the complete ordinal mRS
Mortality at 90 days
Extent of reperfusion after EVT (as graded by the interventionalist using an ordinal score)
Final infarct size (derived from study‐specific MRI or routine CT)
Neurological symptoms (NIHSS) at 7 days (or discharge)
Time from start of anaesthesia to puncture for arterial sheath placement
Time from arterial puncture to reperfusion (or, in the case of unsuccessful efforts, to the last attempt)
Frequency of change from sedation to GA: proportion of participants initially awake or under sedation but subsequently intubated
|
Starting date |
6 April 2021 |
Contact information |
Mr Dr med Andreas Ranft, Klinikum rechts der Isar der TU München, Ismaninger Str 22, 81675, München, Germany Telephone: 089 4140 9632; Fax: 089 4140 4886; E‐mail: andreas.ranft at mri.tum.de; URL: www.med.tu-muenchen.de
|
Notes |
DRKS00023679 |