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NCT Number: NCT01964274

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesia, Klinik für MIC, Berlin, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Postoperative Delirium

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

    Postoperative Delirium (measured by Nursing Delirium Screening Scale)

Secondary outcomes

  1. Organ Dysfunctions

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

  2. Concomitant medication

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

    Concomitant medications from Anticholinergic Drug Scale (ADS)

  3. Postoperative Pain

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

    According to Numeric Rating Scale

  4. Duration of Intensive Care Unit Stay

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

  5. Duration of Hospital Stay

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

  6. Duration of Mechanical Ventilation

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

  7. Readmission rate

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

  8. Hospital Treatment Data

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

    Operation time, surgery, anaesthesia

  9. Postoperative Mortality

    Time frame: 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))

  10. Postoperative Delirium

    Time frame: 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))

  11. Comorbidities

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Acronym: CESARO

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Oct 17, 2013
Registry last updated
Aug 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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