Rivastigmine for Antimuscarinic Delirium

Conditions

• Anticholinergic Toxicity

Eligibility Criteria

Sex

ALL

Age

10 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Rivastigmine — DRUG
  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
• Placebo — DRUG
  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

Study Details

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.

Key Dates

Start date

Jun 30, 2026

Status verified

Jun 2026

Primary completion

Nov 30, 2028

Completion

Dec 31, 2028

Study Design

Enrollment

42 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Rivastigmine
  Patients in the rivastigmine arm will receive 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 up to three doses.
• Placebo Comparator: Placebo
  Patients in the placebo arm will receive oral placebo by mouth once, followed by oral placebo every 1 hour as needed for ongoing delirium or agitation (at the discretion of the treating physician), for up to three doses.

Primary Outcome Measure

Time to control of agitation and delirium [ Time Frame: Typically 8-36 hours after randomization ]

Central Contacts

• Kevin Baumgartner, MD
  3142731109
  [email protected]

Locations (1)

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