The Anaesthetic Ketamine as Treatment for Patients With Severe Acute Brain Injury
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorRigshospitalet, Denmark
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- S-ketamine
- Isotonic saline (placebo)
Treatment groups
400 Participants
are divided into 2 treatment groupsSponsors and collaborators
Rigshospitalet, Denmark
Lead sponsor
Copenhagen Trial Unit, Center for Clinical Intervention Research
Collaborator
Source ClinicalTrials.gov