2-StaLiPost-operative Cognitive Dysfunction (POCD) and Delirium in Patients Undergoing Two-stage Liver Operation - a Pilotstudy
Data Collection
Collected from today forward - ProspectiveMental Disorders+6
+ Confusion
+ Nervous System Diseases
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: March 11, 2013
Actual date on which the first participant was enrolled.Cognitive outcome (delirium and post-operative cognitive deficiency) in patients undergoing two-time liver resection.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.23 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Group: Inclusion Criteria: Patients undergoing a planned elective in situ split liver operation with following resection after approximately ten days with or without additional elective surgery in the same session at the University Hospital, Campus Virchow-Klinikum of the Charité - University Medicine Berlin Patients aged greater than or equal to 18 years Patients of both genders Offered patient information and written informed consent No participation in another clinical trial according to the German Drug Law (AMG) during the trial and one month before inclusion Exclusion Criteria: Lacking willingness to save and hand out pseudonymised data within the clinical study Accommodation in an institution due to an official or judicial order Staff of Charite University hospital Berlin, Virchow Klinikum Illiteracy Unability of German language use Visual and acoustical impairment core on the mini mental state examination (MMSE) at screening of 23 or less American Society of Anaesthesiologists (ASA) Classification greater than IV Ascertained psychiatric disease Intake of psychotropic drugs (including sleeping pills and Benzodiazepine) Symptomatic bradycardia Symptomatic heart rhythm disorder (arrhythmia) Coronary heart disease Canadian Society of Anaesthesiologists criteria (CSC) stadium IV or the presentation of a coronary heart disease that needs intervention Control Group: Inclusion criteria: •Male and female ASA II/III patients, aged ≥ 18 years Exclusion Criteria: Mini-Mental-State-Examination ≤ 23 Points Neuropsychiatric morbidity, which limits the conduction of the neurocognitive testing Taking psychothropic drugs (including sleep-inducing drug and benzodiazepine) on a regular basis
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte and Campus Virchow-Klinikum
Berlin, GermanyOpen Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte and Campus Virchow-Klinikum in Google Maps