CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 19 enrolled
Drug / intervention
Physostigmine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03090620
NCT03090620Phase 4Completed

A Randomized Trial Comparing Physostigmine vs Lorazepam for Treatment of Adolescent Antimuscarinic (Anticholinergic) Toxidrome

University of Colorado, Denver·interventional·Posted Mar 27, 2017·Updated Aug 23, 2021

In Brief

A Phase 4 clinical trial evaluating Physostigmine and Lorazepam for Anticholinergics Toxicity. Completed, enrolled 19 participants across 1 site.

Detailed Summary

Overdose of xenobiotics (antihistamines, antipsychotics, or Jimson Weed) with resulting antimuscarinic toxidrome is a common scenario in medical toxicology. The result of antagonism of muscarinic receptors is a constellation of signs and symptoms (toxidrome): mydriasis, decreased sweat, decreased bowel sounds, agitation, delirium, hallucinations, urinary retention, tachycardia, flushed skin and seizures. Two treatment options are physostigmine or benzodiazepines. Although the antimuscarinic toxidrome occurs commonly, physostigmine has been used sparingly despite evidence of safety and efficacy. To demonstrate the utility and safety of physostigmine, the investigators propose a randomized clinical trial of physostigmine compared to benzodiazepine for antimuscarinic toxicity.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 27, 2017
Enrollment StartMar 30, 2017
Primary CompletionJul 31, 2020
Study CompletionAug 31, 2020
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 9.3 years ago

Interventions

Physostigminedrug

Administration of physostigmine bolus followed by an infusion

Lorazepamdrug

Administration of lorazepam bolus followed by normal saline infusion