Relevance of the Peripheral Cholinesterase-activity on Neurocognitive Dysfunctions in Surgical Patients

N/ACompletedNCT01964274

Charite University, Berlin, Germany815 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

815

Conditions

Postoperative Delirium

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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)

Locations (9)

Department of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin

Berlin, 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 Heidelberg

Heidelberg, Germany

Department of Anesthesiology, Klinikum Großhadern of the Ludwig Maximilians University of Munich

München, Germany

Department of Anesthesiology, Universitätsklinikum Regensburg

Regensburg, Germany

Department of Anesthesiology, Universitätsklinikum Ulm

Ulm, Germany

Department of anesthesiology and intensive care medicine

Wetzlar, Germany

Department of Anaesthesia and Critical Care, Universitätsklinikum Würzburg

Würzburg, Germany

Outcomes

Primary Outcomes

Postoperative Delirium

Postoperative Delirium (measured by Nursing Delirium Screening Scale)

Time frame: Participants will be followed in the sample period, an exspected average of three days

Secondary Outcomes

Organ Dysfunctions

Time frame: Participants will be followed in the sample period, an exspected average of three days

Concomitant medication

Concomitant medications from Anticholinergic Drug Scale (ADS)

Time frame: Participants will be followed in the three postoperative days sample period

Postoperative Pain

According to Numeric Rating Scale

Time frame: Participants will be followed in the three postoperative days sample period

Duration of Intensive Care Unit Stay

Time frame: Participants will be followed in the sample period, an exspected average of seven days

Duration of Hospital Stay

Time frame: Participants will be followed in the sample period, an exspected average of four weeks

Duration of Mechanical Ventilation

Time frame: Participants will be followed in the sample period, an exspected average of 168 hours

Readmission rate

Time frame: Participants will be followed in the sample period, an exspected average of four weeks

Hospital Treatment Data

Operation time, surgery, anaesthesia

Time frame: Participations will be followed for the duration of the operation day, an exspected time average of eight hours

Postoperative Mortality

Mortality (measured inhouse-mortality according to the patients´records and based on the data record according to §21 Krankenhausentgeltgesetz - (KHEntgG))

Time frame: Participants will be followed for the duration of the sample period an exspected average of five years

Postoperative Delirium

Postoperative Delirium (measured by Diagnosis of Delirium according to the patients´records and based on the data record according to §21 Krankenhausentgeltgesetz -(KHEntgG))

Time frame: Participants will be followed in the sample period, an exspected average of five years

Comorbidities

Comorbidities based on the data record according to §21 Krankenhausentgeltgesetz - (KHEntgG)

Time frame: Participants will be followed in the sample period, an exspected average of five years