Rivastigmine for Antimuscarinic Delirium: a Randomized, Placebo-controlled Trial
Washington University School of Medicine
Summary
Antimuscarinic delirium (AMD) is a common and dangerous toxicology condition caused by poisoning by medications and other chemicals that block muscarinic receptors. Physostigmine, the standard antidote for AMD, currently has very limited availability in the United States due to an interruption of production. Recent case reports and small observational studies suggest that rivastigmine might be useful in the treatment of AMD, but there is not direct prospective evidence comparing rivastigmine to physostigmine or supportive care. In order to investigate the effectiveness of rivastigmine, the investigators propose a randomized, placebo-controlled clinical trial of rivastigmine for AMD. The investigators hypothesize that patients treated with rivastigmine for antimuscarinic delirium will experience more rapid resolution of agitation and delirium than those treated with placebo.
Eligibility
- Age range
- 10+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 10 years of age or older * Diagnosis of antimuscarinic delirium by history and physical examination, in the opinion of the treating attending toxicologist. * Reasonably likely to benefit from antidotal therapy for antimuscarinic delirium, as demonstrated by clinically significant agitation and delirium: 1. Richmond Agitation-Sedation Scale (RASS) of +1 or higher at the time of enrollment 2. Positive for delirium as defined by the Confusion Assessment Method for the ICU (CAM-ICU) Exclusion Criteria: * Age less than 10 years at time of enrollment * Surrogate decisio…
Interventions
- DrugRivastigmine
Rivastigmine 3mg by mouth once, followed by rivastigmine 1.5mg by mouth every 1 hour as needed for ongoing delirium or agitation (at the discretion of the treating physician), for a maximum of three doses
- DrugPlacebo
Matching oral placebo by mouth once, followed by placebo by mouth every 1 hour as needed for ongoing delirium or agitation (at the discretion of the treating physician), for a maximum of three doses
Location
- Washington University School of MedicineSt Louis, Missouri