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S-KETamine vs. propofol for prehospital sedation of patients with severe Acute Brain Injury: The KETABI randomised trial

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2026-525588-41-00
Enrollment
284
Registered
2026-08-27
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-27

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

Conditions

traumatic brain injury, subarachnoid haemorrhage, intracerebral haemorrhage

Brief summary

Lowest mean arterial pressure (MAP) recorded during the intervention period referring to the period from administration of the investigational medicinal product until the departure from the trauma centre.

Detailed description

Episode(s) of hypotension (MAP <60 mmHg) measured in the intervention period, Episode(s) of hypertension (MAP >130 mmHg) measured in the intervention period, Episode(s) of hypoxaemia (two successive measurements of SpO2<94%) measured in the intervention period, Functional outcome using GOSE six months after randomisation (1–8 scale), Functional outcome using mRS six months after randomisation (1–6 scale)

Interventions

DRUGPROPOFOL
DRUGopløsning

Sponsors

Region Hovedstaden
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Lowest mean arterial pressure (MAP) recorded during the intervention period referring to the period from administration of the investigational medicinal product until the departure from the trauma centre.

Secondary

MeasureTime frame
Episode(s) of hypotension (MAP <60 mmHg) measured in the intervention period, Episode(s) of hypertension (MAP >130 mmHg) measured in the intervention period, Episode(s) of hypoxaemia (two successive measurements of SpO2<94%) measured in the intervention period, Functional outcome using GOSE six months after randomisation (1–8 scale), Functional outcome using mRS six months after randomisation (1–6 scale)

Outcome results

None listed

Source: EU CTIS · Data processed: Aug 28, 2026