Relevance of the Peripheral Cholinesterase-activity on Neurocognitive Dysfunctions in Surgical Patients
- Conditions
- Postoperative Delirium
- Registration Number
- NCT01964274
- Lead Sponsor
- Charite University, Berlin, Germany
- Brief Summary
In this prospective, multicenter observational study the investigators capture the perioperative course of peripheral cholinesterase activity. The focus is the perioperative inflammation causing postoperative delirium. Therefore we measure the activity of Acetylcholine-Esterase and Butyrylcholine-Esterase in whole blood of adults in the perioperative context. Early postoperative delirium will be detected by Nu-DESC in the Recovery Room or the Postanaesthesia-Care-Unit. The course of the peripheral cholinesterase activity will be compared with the incidence of postoperative delirium and other clinical dysfunctions.
We follow up the patients for up to five years regarding Delirum, comorbidities and mortality data.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 815
- Male and female patients with age 18 years and above scheduled for surgery with planned stay in Recovery Room or Postanesthesia-Care-Unit
- Offered patient information and written informed consent
- In-hospital stay for at least 24 hours
- Patients with known pseudocholinesterase deficiency
- Participation in prospective intervention studies during the study period
- Analphabetism
- Unability of German and English language use
- Anacusis or Hypoacusis with hearing aid device, Amaurosis
- Lacking willingness to save and hand out data within the study
- Accommodation in an institution due to an official or judicial order
- Coworker of the clinic (study center)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Postoperative Delirium Participants will be followed in the sample period, an exspected average of three days Postoperative Delirium (measured by Nursing Delirium Screening Scale)
- Secondary Outcome Measures
Name Time Method Organ Dysfunctions Participants will be followed in the sample period, an exspected average of three days Concomitant medication Participants will be followed in the three postoperative days sample period Concomitant medications from Anticholinergic Drug Scale (ADS)
Postoperative Pain Participants will be followed in the three postoperative days sample period According to Numeric Rating Scale
Duration of Intensive Care Unit Stay Participants will be followed in the sample period, an exspected average of seven days Duration of Mechanical Ventilation Participants will be followed in the sample period, an exspected average of 168 hours Readmission rate Participants will be followed in the sample period, an exspected average of four weeks Postoperative Mortality Participants will be followed for the duration of the sample period an exspected average of five years Mortality (measured inhouse-mortality according to the patients´records and based on the data record according to §21 Krankenhausentgeltgesetz - (KHEntgG))
Duration of Hospital Stay Participants will be followed in the sample period, an exspected average of four weeks Hospital Treatment Data Participations will be followed for the duration of the operation day, an exspected time average of eight hours Operation time, surgery, anaesthesia
Postoperative Delirium Participants will be followed in the sample period, an exspected average of five years Postoperative Delirium (measured by Diagnosis of Delirium according to the patients´records and based on the data record according to §21 Krankenhausentgeltgesetz -(KHEntgG))
Comorbidities Participants will be followed in the sample period, an exspected average of five years Comorbidities based on the data record according to §21 Krankenhausentgeltgesetz - (KHEntgG)
Trial Locations
- Locations (9)
Department of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin
🇩🇪Berlin, Germany
Department of Anesthesiology, Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Germany
Department of Anesthesiology, Klinikum Großhadern of the Ludwig Maximilians University of Munich
🇩🇪München, Germany
Department of Anesthesia, Klinik für MIC
🇩🇪Berlin, Germany
Clinic for Anaesthesiology, Intensive Care Medicine, Palliative Medicine and Pain Medicine, Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil
🇩🇪Bochum, Germany
Department of Anesthesiology, Universitätsklinikum Ulm
🇩🇪Ulm, Germany
Department of anesthesiology and intensive care medicine
🇩🇪Wetzlar, Germany
Department of Anesthesiology, Universitätsklinikum Regensburg
🇩🇪Regensburg, Germany
Department of Anaesthesia and Critical Care, Universitätsklinikum Würzburg
🇩🇪Würzburg, Germany