This double-blind, placebo-controlled randomized multicentre clinical trial (n=100) aims to investigate the safety and feasibility of using ketamine as an adjunct to a standard sedative strategy in Traumatic Brain Injury (TBI) patients.
The BIKe study is a double-blind, placebo-controlled randomised multicentre trial evaluating racemic ketamine as an adjunct to standard sedation in adult TBI patients, with primary outcomes including intracranial pressure control and therapy intensity level.
Racemic ketamine is administered as a continuous infusion (1 mg/kg/h, max 120 mg/h; infusion rate 0.02 ml/kg/h, max 2.4 ml/h; concentration 50 mg/ml) started after randomisation; background sedation uses propofol (up to 4 mg/kg/h) with addition of midazolam if required, and opioids for analgesia, per site standard care.
Continuous racemic ketamine infusion as adjunct to standard sedation for TBI patients.
Racemic ketamine 1 mg/kg/h; max 120 mg/hour; concentration 50 mg/ml; infusion rate 0.02 ml/kg/h (max 2.4 ml/h); started within 6 hours after randomization.
Normal saline infusion at same rate as ketamine.
0.9% NaCl administered at 0.02 ml/kg/h (max 2.4 ml/h) matching ketamine infusion.