Perioperative physostigmine prophylaxis for liver resection patients at postoperative risk for confusion, lack of concentration and orientation and postoperative cognitive dysfunction.
- Conditions
- 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.Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2008-007237-47-DE
- Lead Sponsor
- Charité - Universitätsmedizin Berlin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
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
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).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method