Anesthetic care during thrombectomy for stroke A randomized clinical study

Austria, Germany, Switzerland (ICTRP)

ICTRP Trial ID
DRKS00023679 (ICTRP)

Official title (approved by ethics committee)
not available

Academic title
Anaesthesiological Care for Thrombectomy in Stroke - ACT in Stroke (ICTRP)

Public title
Anaesthesiological Care for Thrombectomy in Stroke (ICTRP)

Disease under investigation

I63.5
I63.2Cerebral infarction due to unspecified occlusion or stenosis of cerebral arteriesCerebral infarction due to unspecified occlusion or stenosis of precerebral arteriesI63.5I63.2 (ICTRP)

Intervention under investigation
Group 1: General anaesthesia during endovascular thrombectomy
Group 2: Sedation (or standby) during endovascular thrombectomy (ICTRP)

Type of trial
interventional (ICTRP)

Trial design
Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: active; Assignment: parallel; Study design purpose: treatment (ICTRP)

Inclusion/Exclusion criteria
Inclusion criteria: Acute ischemic stroke due to arterial occlusion in the anterior cerebral circulation (i. e., internal carotid artery and/or middle cerebral artery and/or anterior cerebral artery), decision for endovascular thrombectomy (ICTRP)

Exclusion criteria: Suspected procedural technical difficulties while reaching the target occlusion, isolated extracranial arterial occlusion, in-hospital onset of stroke or in-hospital worsening of symptoms, mild neurological deficit (NIH stroke scale < 5), mandatory general anaesthesia 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 (Richmond Agitation Sedation Scale +3 or +4), contraindication to general anaesthesia, such as manifest or expected haemodynamic instability (e.g., shock, or known severe aortic stenosis), or COPD with home oxygen, suspected difficult airway, inclusion in another interventional study, age < 18 years

Primary and secondary end points
After 90 days: Proportion of patients with mRS less than or equal to mRS before stroke or within 0�2 (ICTRP)

Functional outcome at 30 and 90 days using the full mRS; mortality at 30 and 90 days; extent of reperfusion after ET (as graded by interventionalist using an ordinal score); final infarct size (derived from study-specific MRI or routine cCT); neurological symptoms (NIH stroke scale) at 24 hours and 7 days (or discharge, if earlier); time from start of anaesthesia care to puncture for arterial sheath placement; time from arterial puncture to reperfusion (or, in case of futility, last attempt to remove clot); proportion of patients whose mean arterial pressure dropped 20 % or more of pre-procedural values before recanalization; frequency of conversion from PS to GA: proportion of patients primarily treated awake or with PS that were subsequently treated with GA (ICTRP)

Registration date
06.04.2021 (ICTRP)

Incorporation of the first participant
01.07.2021 (ICTRP)

Secondary sponsors
not available

Additional contacts
Andreas Ranft, andreas.ranft@mri.tum.de, 089 4140 9632, Klinikum rechts der Isar der TU Mnchen (ICTRP)

Secondary trial IDs
13/21 S-SR (ICTRP)

Results-Individual Participant Data (IPD)
YesThe anonymised pooled data set can be made available for secondary analyses together with the study protocol. For this purpose, a specific request must be made to the steering committee in the form of a detailed study protocol after the initial publication. Prior to submission for publication, each article derived from the pooled data will be reviewed by the steering committee. (ICTRP)

Further information on the trial
http://drks.de/search/en/trial/DRKS00023679 (ICTRP)