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GOLIATH - General Or Local Anaestesia in Intra Arterial THerapy

Anaesthetic Strategy During Endovascular Therapy: General Anaesthesia or Conscious Sedation ?

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02317237
Acronym
GOLIATH
Enrollment
128
Registered
2014-12-15
Start date
2015-03-08
Completion date
2017-05-02
Last updated
2017-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Cerebral Revascularization, Stroke

Brief summary

Patients suffering a stroke with a large vessel occlusion is often treated intra veneous thrombolyse and on top of that also intra arterial therapy. It is unknown what form of anaestesia is best during intra arterial therapy. The investigators will randomize these patients between general anaestesia and local anaestesia. Outcome will be growth of the ischemic lesion as judged on an MRI scan.

Interventions

PROCEDURELocal anesthesia

Conscious sedation

Sponsors

Aarhus University Hospital
CollaboratorOTHER
University of Aarhus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* NIHSS\>10 * mRS=\<2 * groin puncture\<6hours from stroke onset * occlusion of ICA, ICA-T, M1, M2

Exclusion criteria

* MRI contraindications * GCS\<9 * intubated prior to arrival * posterior circulation stroke * allergy to anestetics

Design outcomes

Primary

MeasureTime frame
Growth of DWI lesion48-72 hours

Secondary

MeasureTime frame
Time from arrival to groin puncture and recanalization1-2 hours
Blood pressure during intervention1-2 hours
Modified Rankin Score90 days

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026