Evaluation if physostigmin reduces symptoms in patients who has developed a delirium in Intensive care after a surgery

Monocenter, double blind, randomised, placebo controlled study t evaluate Physostigmin for the Treatment of delirium in perioperative intensive care medicine

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-004082-41-DE

Enrollment

120

Registered

2013-01-14

Start date

2013-03-06

Completion date

Unknown

Last updated

2021-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients with delirium in perioperative intensive care medicine MedDRA version: 17.1 Level: HLGT Classification code 10012221 Term: Deliria (incl confusion) System Organ Class: 10037175 - Psychiatric disorders

Interventions

Trade Name: Anticholium Product Name: Physostigmin Pharmaceutical Form: Solution for injection Pharmaceutical form of the placebo: Injection Route of administration of the placebo: Intravenous use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients of both genders aged > 18 years, 18a, =65 years) yes F.1.3.1 Number of subjects for this age range 60

Exclusion criteria

Exclusion criteria: - Asthma - hypersensitivity against Physostigminsalicylat, Sodium metabisulfit, Nitrogen - gangrene - mechanical obstipation - mechanical urinary retention - Dystrophia myotonica - Depolarization block after depolarising muscle relaxants - Intoxications with „irreversibly acting“ cholinesterase inhibitors - closed head trauma - obstructions at gastro-intestinal tract and at urinary tract - neurological diseases - left ventricular ejection fraction < 40% - Simultaneous Participation in other clinical trials or participation ind other clinical trials in the last 30 days - untreated coronary heart disease - wish to have chirldren, pregnancy or nursing - patients with addicitve disorder in medical history

Design outcomes

Primary

Measure	Time frame
Main Objective: Improvement of vigilance or symptoms of the delirum after administration of physostigmin measured by Richmond Agitation Sedation Score (RASS).;Secondary Objective: a) reduction of weaning time at mechanical ventilator of patients with symptoms of delirium b) impact on the spontaneous EEG and auditory evoked potentials c) impact of the variability of heart rate d) impact of development of muscular force ;Primary end point(s): Improvement of vigilance or symptoms of the delirum after administration of physostigmin measured by Richmond Agitation Sedation Score (RASS).;Timepoint(s) of evaluation of this end point: 30 minutes, 2 , 24 and 48 hours and 4 weeks after begin of administration of IMP/placebo	—

Measure

Time frame

Main Objective: Improvement of vigilance or symptoms of the delirum after administration of physostigmin measured by Richmond Agitation Sedation Score (RASS).;Secondary Objective: a) reduction of weaning time at mechanical ventilator of patients with symptoms of delirium b) impact on the spontaneous EEG and auditory evoked potentials c) impact of the variability of heart rate d) impact of development of muscular force ;Primary end point(s): Improvement of vigilance or symptoms of the delirum after administration of physostigmin measured by Richmond Agitation Sedation Score (RASS).;Timepoint(s) of evaluation of this end point: 30 minutes, 2 , 24 and 48 hours and 4 weeks after begin of administration of IMP/placebo

—

Secondary

Measure	Time frame
Secondary end point(s): reduction of weaning time at mechanical ventilator of patients with symptoms of delirium impact on the spontaneous EEG and auditory evoked potentials impact of the variability of heart rate impact of development of muscular force ;Timepoint(s) of evaluation of this end point: 30 minutes, 2 , 24 and 48 hours and 4 weeks after begin of administration of IMP/placebo	—

Countries

Germany

Contacts

Public ContactClinical Tials Information

PD Dr. Bertram Scheller, Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie der JWG-Univ. Frankfurt a.M.

bertram.scheller@kgu.de00496963017696

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026