| Study name |
SEGA – sedation versus general anaesthesia for endovascular therapy in acute ischemic stroke – a randomised comparative effectiveness trial |
| Methods |
Setting: single‐centre, USA
Design: RCT, 2 arms, parallel assignment, open‐label single‐blind
Start date: 16 August 2017 (reported in protocol)
Completion date: 31 December 2021 (reported in protocol) |
| Participants |
260 men and women aged 18–90 years
Inclusion criteria
-
AIS due to large intracranial vessel occlusion demonstrated on CTA in the following anterior circulation locations that will be treated by EVT:
Participants who receive IV tPA thrombolysis are eligible provided the drug was delivered within 4.5 hours of stroke onset or last seen normal and in accordance with local hospital standard of care Aged 18–90 years NIHSS score 6–30 Time from stroke symptom onset of last seen normal to start of EVT (defined as groin puncture) ≤ 16 hours -
Limited infarct core, as defined below and adapted from the 2018 American Heart Association guidelines
for participants presenting ≤ 6 hours from the time of symptom onset or last seen normal, ASPECTS ≥ 6 for participants presenting > 6 hours and ≤ 16 hours from the time of symptom onset or last seen normal, they must satisfy EITHER 1 of the 2 following criteria: (i) ischaemic core by CT perfusion or MRI/MR perfusion < 70 mL, a ratio of the volume of penumbral tissue to infarct core of ≥ 1.8, and an absolute volume of penumbral tissue of ≥ 15 mL OR (ii) for participants with NIHSS ≥ 10, infarct core of < 31 mL by CT perfusion or MRI; for participants with NIHSS ≥ 20, infarct core < 51 mL
Participant willing/able to return for protocol required to follow‐up visits No significant prestroke disability (mRS must be ≤ 2) Women of childbearing potential must have a negative serum or urine pregnancy test Participant or participant's legally authorised representative has given informed consent according to good clinical practices or local Institutional Review Board policies
Exclusion criteria
Coma on admission (GCS < 8), need for intubation upon emergency department arrival, or transferred patients who present previously intubated Severe agitation or seizures on admission that preclude safe vascular access Loss of airway protective reflexes or vomiting (or both) on admission Predicted or known difficult airway Pre‐existing neurological or psychiatric disease that would confound the neurological or functional evaluations, e.g. dementia Presumed septic embolus or suspicion of bacterial endocarditis Currently participating or has participated in any investigational drug or device study within 30 days Inability to follow‐up for 90‐day assessment Known history of allergy to anaesthesia drugs Known history or family history of malignant hyperthermia
|
| Interventions |
Experimental: GA
Comparator: CSA |
| Outcomes |
Primary outcomes
Secondary outcomes
Dichotomised mRS (time frame: 90 days), dichotomised mRS at 90 days (0–2 vs 3–6) adjusted for stratification variable rates of recanalisation (time frame: postprocedure within 6 hours) Rates of recanalisation using mTICI scores NIHSS scale (time frame: 24–36 hours postprocedure). Early clinical improvement measured by difference NIHSS scale mRS (time frame: 90 days) Quality of life assessed by the European Quality of Life‐5 Dimensions (EQ‐5D) instrument (time frame: 90 days) Incidence of symptomatic intracerebral haemorrhage (time frame: 18–36 hours postprocedure). Safety measured by incidence of symptomatic intracerebral haemorrhage Incidence of mortality (time frame: 18–36 hours postprocedure). Safety measured by incidence of mortality Incidence of device‐related complications (time frame: 18–36 hours postprocedure). Safety measured by incidence of device‐related complications
|
| Starting date |
16 August 2017 |
| Contact information |
Peng Roc Chen
University of Texas Health Science Center, USA
713‐486‐8016; peng.r.chen@uth.tmc.edu
|
| Notes |
NCT03263117 |
