Randomised, quadruple-blind, parallel-group trial (n=116) assessing intraoperative IV esketamine 0.3 mg/kg versus saline on consciousness measures in patients with prolonged disorders of consciousness undergoing surgery under sevoflurane anaesthesia.
This parallel, randomised, quadruple-blind study will compare a single intraoperative IV infusion of subanaesthetic esketamine (0.3 mg/kg over 30 minutes) to matched normal saline in patients with prolonged disorders of consciousness undergoing surgery under sevoflurane anaesthesia.
Primary and secondary assessments include Coma Recovery Scale–Revised, Glasgow Coma Scale, Full Outline of UnResponsiveness scores, SedLine multichannel EEG measures and perioperative adverse events; outcomes measured acutely and in the perioperative period.
Intravenous esketamine 0.3 mg/kg infused over 30 minutes after tracheal intubation.
50 mg vial dissolved in 50 ml saline; infused over 30 min within 30 min after intubation.
Placebo comparator: same volume of normal saline infused at same rate.
50 ml normal saline infused over 30 min within 30 min after intubation (placebo comparator).