The Anesthetic Ketamine as Treatment for Patients With Severe Acute Brain Injury

• Status: Not yet recruiting
• Trial end date: 2026-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rigshospitalet, Denmark
• Collaborator: Copenhagen Trial Unit, Center for Clinical Intervention Research
• Treatments: Esketamine; Ketamine

Criteria

Inclusion Criteria:

• Age ≥ 18 years.

• Admitted to the NICU with a diagnosis of TBI, aneurysmal SAH or spontaneous ICH.

• Planned for surgery with a craniotomy or craniectomy.

• Expected to continue sedation and mechanical ventilation after surgery.

Exclusion Criteria:

• Patient and next of kin do not read or understand spoken Danish.

• Known allergy to S-ketamine (the active pharmaceutical ingredient or the excipients).

• Immediate wake-up call planned after surgery.

• Pregnancy (all female participants aged ≤ 50 years will have a blood hCG to control for pregnancy).

• Current abuse of ketamine.

• Active anti-psychotic treatment.

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.