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

NCT01964274 | Completed

• 1 other identifier: CESARO
• Study Type: observational
• Target: 815
• Locations: 1 country
• Sites: 9

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.

Conditions

Postoperative Delirium

Keywords

Nursing Delirium Screening Scale,; Acetylcholinesterase Activity

Outcome Measures

Primary Outcomes (1)

• Postoperative Delirium

  Postoperative Delirium (measured by Nursing Delirium Screening Scale)

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

Secondary Outcomes (11)

• 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

• Postoperative Pain

  Participants will be followed in the three postoperative days sample period

• Duration of Intensive Care Unit Stay

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

• Duration of Hospital Stay

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

Study Arms (1)

Surgical patients

Adult male and female patients undergoing surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult, elective surgery patients of both gender

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (9)

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

Berlin, 13353, Germany

Location

Department of Anesthesia, Klinik für MIC

Berlin, 14129, Germany

Location

Clinic for Anaesthesiology, Intensive Care Medicine, Palliative Medicine and Pain Medicine, Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil

Bochum, 44789, Germany

Location

Department of Anesthesiology, Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

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

München, 81377, Germany

Location

Department of Anesthesiology, Universitätsklinikum Regensburg

Regensburg, 93053, Germany

Location

Department of Anesthesiology, Universitätsklinikum Ulm

Ulm, 89081, Germany

Location

Department of anesthesiology and intensive care medicine

Wetzlar, 35578, Germany

Location

Department of Anaesthesia and Critical Care, Universitätsklinikum Würzburg

Würzburg, 97080, Germany

Location

Related Publications (2)

• Muller A, Olbert M, Heymann A, Zahn PK, Plaschke K, von Dossow V, Bitzinger D, Barth E, Meister M, Kranke P, Herrmann C, Wernecke KD, Spies CD. Relevance of peripheral cholinesterase activity on postoperative delirium in adult surgical patients (CESARO): A prospective observational cohort study. Eur J Anaesthesiol. 2019 Feb;36(2):114-122. doi: 10.1097/EJA.0000000000000888.

  PMID: 30431498 RESULT

• Michels B, Holzamer A, Graf BM, Bredthauer A, Petermichl W, Muller A, Zausig YA, Bitzinger DI. Butyrylcholinesterase as a perioperative complication marker in patients after transcatheter aortic valve implantation: a prospective observational study. BMJ Open. 2021 Jul 6;11(7):e042857. doi: 10.1136/bmjopen-2020-042857.

  PMID: 34230011 DERIVED

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Claudia Spies, MD

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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charite - Universitätsmedizin Berlin, Germany

Study Record Dates

• First Submitted: October 15, 2013
• First Posted: October 17, 2013
• Study Start: October 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: August 21, 2019

Record last verified: 2019-08

Locations

DE (9)