S-ketamine: S-ketamines is an NMDA-receptor antagonist with sedative and analgesic properties. It will in the present trial be given in sedative doses (2-3 mg/kg/hour) in case of clustered SDs following a dosing algorithm according to SD occurrence.
Isotonic saline (placebo): Isotonic saline has the same appearance as S-ketamine with both being clear liquids with no bubbles or other distinguishing features.
Study summary
Cortical spreading depolarisations are pathological depolarisation waves that occur frequently after severe acute brain injury and has been associated with poor outcome. S-ketamine has been shown to inhibit cortical spreading depolarisations. The aim of the present study is to examine the efficacy and safety of using S-ketamine for treatment of patients with severe acute brain injury, as well as the feasibility of the trial design.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Age ≥ 18 years.
* Admitted to the NICU with a diagnosis of traumatic brain injury (TBI), aneurysmal subarachnoid haemorrhage (aSAH) or spontaneous intracerebral haemorrhage (ICH).
* Planned for surgery with a supratentorial craniotomy or craniectomy.
* Expected to continue sedation and mechanical ventilation after surgery.
Exclusion Criteria:
* Neither patient or next of kin understand Danish or English.
* Known allergy to S-ketamine (the active pharmaceutical ingredient or the excipients).
* Wake-up call to occur immediately after surgery.
* Pregnancy (all female participants aged ≤ 50 years will have a urine or blood hCG taken to control for pregnancy).
* Active anti-psychotic treatment before admission.
* Current abuse of ketamine.
* Decision to withdraw active treatment.
* ICH secondary to a known brain tumour at the time of inclusion.
Since this is an emergency trial informed consent will be obtained from a trial guardian before inclusion of the participant, and informed consent will be sought from next of kin as soon as possible.
Primary outcome measure(s)
Occurrence of SDs after randomisation — From randomisation to end of ECoG monitoring, expected to be a maximum of 14 days Efficacy of S-ketamine on the occurrence of cortical spreading depolarisations
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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