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

Launched by RIGSHOSPITALET, DENMARK · Oct 14, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the use of S-ketamine, a type of anesthetic, to help patients who have experienced severe acute brain injuries, such as traumatic brain injuries or brain hemorrhages. After such injuries, some patients may experience harmful brain waves called cortical spreading depolarizations, which can lead to poor recovery. The trial aims to see if S-ketamine can safely reduce these harmful waves and improve patient outcomes.

To participate in this study, patients must be at least 18 years old and admitted to the Neuro Intensive Care Unit (NICU) with specific types of brain injuries. They should also be scheduled for surgery that involves opening the skull. The trial is open to all genders. Since this is an emergency situation, consent will be obtained from a guardian before participants are included, and efforts will be made to get consent from family members as soon as possible. Participants can expect to receive careful monitoring throughout the trial to ensure their safety.

Gender

ALL

Eligibility criteria

• 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.