Patients with postoperative delirium in the termination phase of anaesthesia after ACVB or aortic valve/mitral valve surgery or double heart intervention (heart-lung-machine (HLM) and mild hypothermia) MedDRA version: 15.1 Level: PT Classification code 10012218 Term: Delirium System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: Anticholium
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Physostigmine salicylate
CAS Number: 57476
Other descriptive name: PHYSOSTIGMINE
Concentration unit: mg/ml milli
Sponsors
Company: Dr. Franz Köhler Chemie GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed Consent), 2. Indication for an elective ACVB or a aortic valve surgery or mitral valve surgery or double heart intervention under use of HLM with mild hypothermia, 3. 18 = age =65 years) yes F.1.3.1 Number of subjects for this age range 65
Exclusion criteria
Exclusion criteria: 1. Known neurological deficite, 2. Known asthma bronchiale 3. Acute bleeding, 4. Acute renal insufficiency, 5. Use of a ciruculation support system, 6. Body weight >130 kg, 7. Concurrent participation in another interventional clinical trial, 8. Concomittant therapy for cerebral impairment and cerebral circulatory disorders, 9. Known intolerance / hypersensitivity to the IMPs or other compounds with similar chemical structure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Investigation of efficacy of physostigminsalicylate on the basis of the Confusion Assessment Method for the Intensive Care Unit Test (CAM-ICU) 30 minutes after administration of the IMP ;Secondary Objective: Investigation of efficacy and tolerability of physostigminsalicylate on the basis of the following parameters: Result of the Confusion Assessment Method for the Intensive Care Unit Test (CAM-ICU) 120 minutes after administration of the IMP Plasma activity of acetylcholinesterase (AChE) 60 minutes after administration of the IMP Result of the Richmond Agitation and Sedation Scales Test (RASS) 30 and 120 minutes after administration of the IMP Adverse Events up to 120 minutes after administration of the IMP Vital parameters (blood pressure, heart rate, fillings pressures and blood oxygen saturation) documented 10, 20, 30, 60 and 120 minutes after administration of the IMP;Primary end point(s): Confusion Assessment Method for the Intensive Care Unit Test (CAM-ICU);Timepoint(s) of evaluation of this end point: 30 minutes after administration of the IMP | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Richmond Agitation and Sedation Scales Plasma activity of AChE and plasma levels of IL-6 and TNFalpha Adverse Events;Timepoint(s) of evaluation of this end point: 30 and 120 minutes after administration of the IMP 60 minutes after administration of the IMP Up to 120 minutes after administration of the IMP | — |
Countries
Germany
Contacts
Public ContactDr. Roman Petrov
Company: Dr. Franz Köhler Chemie GmbH
Outcome results
None listed