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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01964274
Acronym
CESARO
Enrollment
815
Registered
2013-10-17
Start date
2013-10-31
Completion date
2016-07-31
Last updated
2019-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Delirium

Keywords

Nursing Delirium Screening Scale,, Acetylcholinesterase Activity

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.

Interventions

None listed

Sponsors

Charite University, Berlin, Germany
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Postoperative DeliriumParticipants will be followed in the sample period, an exspected average of three daysPostoperative Delirium (measured by Nursing Delirium Screening Scale)

Secondary

MeasureTime frameDescription
Concomitant medicationParticipants will be followed in the three postoperative days sample periodConcomitant medications from Anticholinergic Drug Scale (ADS)
Postoperative PainParticipants will be followed in the three postoperative days sample periodAccording to Numeric Rating Scale
Duration of Intensive Care Unit StayParticipants will be followed in the sample period, an exspected average of seven days
Duration of Hospital StayParticipants will be followed in the sample period, an exspected average of four weeks
Duration of Mechanical VentilationParticipants will be followed in the sample period, an exspected average of 168 hours
Organ DysfunctionsParticipants will be followed in the sample period, an exspected average of three days
Hospital Treatment DataParticipations will be followed for the duration of the operation day, an exspected time average of eight hoursOperation time, surgery, anaesthesia
Postoperative MortalityParticipants will be followed for the duration of the sample period an exspected average of five yearsMortality (measured inhouse-mortality according to the patients´records and based on the data record according to §21 Krankenhausentgeltgesetz - (KHEntgG))
Postoperative DeliriumParticipants will be followed in the sample period, an exspected average of five yearsPostoperative Delirium (measured by Diagnosis of Delirium according to the patients´records and based on the data record according to §21 Krankenhausentgeltgesetz -(KHEntgG))
ComorbiditiesParticipants will be followed in the sample period, an exspected average of five yearsComorbidities based on the data record according to §21 Krankenhausentgeltgesetz - (KHEntgG)
Readmission rateParticipants will be followed in the sample period, an exspected average of four weeks

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026