Psychotomimetic Effects

Esketamine is associated with a lower incidence of psychotropic side effects than racemic ketamine while offering greater potency. The non-inferiority test for the composite psychotomimetic endpoint requires the upper bound of the 95% CI for risk difference to be less than 9%. The primary limitation of the trial is that sample size is powered for desaturation rather than psychotomimetic events, because desaturation is an objective, immediately life-threatening risk while psychotomimetic effects are subjective and language-dependent. The study may not be fully powered to detect modest differences in psychiatric adverse events between esketamine and remifentanil. Psychotomimetic effects are assessed 24 hours after each procedure and include nightmares, nausea, vomiting, fatigue, dizziness, and headache. Observed side effects of ketamine include nightmares, vomiting, diplopia, abnormal behaviour, and dream-like states.