The drug physostigmine will be investigated in patients (men and women)undergoing a liver resection. The study medication will be administered by intravenous infusion continuously (24 hours) to prevent/reduce the rate of Delirium and the incidence of the postoperative cognitive dysfunction.
Conditions
Interventions
Trade Name: Anticholium
Product Name: Anticholium
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Physostigmine Salicylate
CAS Number: 57-64-7
Current Sponsor code: Anticholium
Other d
Sponsors
Charité - Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: male or female patients age = 18 planned elective liver resection with or without additional elective surgery in the same session able to give written informed consent offered patient information and informed consent no participation in another clinical trial (one month before and during the study period) negative pregnancy test (ß-HCG in urine) Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 58 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 213
Exclusion criteria
Exclusion criteria: pregancy or lactation lacking willingness to save and hand out pseudonymised data within the study accomodation in an institution due to an official or judical order Charité employee illiteracy unability of German language use visual and acustical impairment score on the minimental state examination (MMSE) at screening of 23 or less ASA Classification > IV wedge resection ascertained psychiatric disease intake of psychotropic drugs (including sleeping pills and Benzodiazepine) AIDS (CDC - classification "C") Neoadjuvant chemo - or radiotherapy within the last 28 days rheumatoid diseases vagotomy symptomatic bradycardia known prolongation of QTc - interval (> 456 ms) regular intake of amiodarone or cholinesters vagus nerve stimulation in epilepsy asthma bronchiale allergies and sensibility to physostigmine salicylate allergies to any ingredient of the electrode fixing material (only for participants of sleep stage assessment).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Mutiple objective Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV) Cambridge Neurophysiological Test Automated Battery (CANTAB);Secondary Objective: - Diagnostics, Frequency, Duration, Delirium-free days of Delirium - Diagnostics, Frequency, Duration, Delirium-free days of subsyndromal Delirium - Evaluation of intensive care unit performance - Length of postoperative hospital stay - Length of postoperative intensive care unit stay - Pain - The rate of postoperative organ dysfunctions and complications - Incidence of systemic inflammatory response syndrome (SIRS) and infection - Immune parameters - Quality of life (questionnaires) - Mortality - Innovative Parameter of renal function - Parameter of hematology (Sysmex) - Cortisol level - Venous return - Calcification propensity - Heart rate variability - Transthoracic echocardiography ;Primary end point(s): 1. Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV) 2. Cambridge Neurophysiological Test Automated Battery (CANTAB) ;Timepoint(s) of evaluation of this end point: 1. Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV), measured pre-operatively and up the the 7th post-operative day 2. Cambridge Neurophysiological Test Automated Battery (CANTAB), measured pre-operatively, on the 7th, 90th and 365th post-operative day The study will end seven years and 11 months after recruitment of the first Patient. The primary endpoint can be evaluated for every patient after mean follow-up 1 year. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1a. Delirium (Diagnostic, Frequency, Duration, Delirium-free days): Confusion Assessment Method (CAM)/Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) , Intensive Care Delirium Screening Checklist (ICDSC) , Delirium Detection Scale (DDS) , Delirium Rating Scale (DRS) , NuDESC (Nursing Delirium Screening Scale); 1b Delirium (Frequency, Duration, Delirium-free days): DSM IV 1c: Subsyndromal Delirium (Diagnostic, Frequency, Duration, Delirium-free days): Intensive Care Delirium Screening Checklist (ICDSC) , Delirium Detection Scale (DDS), NuDESC (Nursing Delirium Screening Scale) 2. Evaluation of intensive care unit performance: 2.1. Simplifies Acute Physiology Score (SAPS II) 2.2. Acute Physiological and Chronic Health Evaluation (Apache II) 2.3. Sequental Organ Failure Assessment (SOFA) 2.4. Therapeutic Interventions Scoring System (TISS) 2.5. Richmonds Agitation Sedations Scale (RASS) 2.6. Glasgow Coma Scale (GCS) 2.7. Risk Injury Failure Loss End Stage Kidney Disease (RIFLE) 3. Length of post-operative hospital stay, measured by Post-anaesthesia Discharge Scoring Stay (PADSS) 4. Length of post-operative intensive care unit stay according to the criteria of internal standard operating procedures (SOP) 5. Pain: 5.1. Numeric Rating Scale (NRS) 5.2. Verbal Rating Scale (VRS) 5.3. Visual Analogue Scale (VAS) 5.4. Behavioural Pain Scale (BPS) 6. The rate of post-operative organ dysfunctions and complications: cerebral-, cardiovascular-, cardiac- pulmonary-, gastrointestinal- and renal dysfunction 7. Incidence of systemic inflammatory response syndrome (SIRS) and infection, measured by CDC and American Thoracic Society (ATS) criteria 8. Laboratory parameters of immunology and hematology (Sysmex) 9.1 Quality of life (questionnaires): 12-item short form health survey (SF-12), EuroQoL instrument (EQ-5D) 9.2. Barthel Index (ADL/IADL)/Instrumental Activity of Daily Living (IATL) (German: Instrumentelle Aktivität im | — |
Countries
Germany
Contacts
Public ContactUniv. - Prof. Dr. Claudia Spies
Charité - Universitätsmedizin Berlin
Outcome results
None listed