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NCT02315846 Clinical Trial

Acetylcholinesterase in Postoperative Delirium

Delirium Clinical Trial

Official title:
Role of Acetylcholinesterase for the Diagnosis of Postoperative Delirium in Patients Needing Postoperative Monitoring

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02315846
Other study ID # S452/2013
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2014
Est. completion date July 2014

Study information
Verified date May 2018
Source Heidelberg University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The level of acetylcholinesterase is suspected to correlate with postoperative delirium. The investigators therefore score patients once preoperatively and twice postoperatively with the german version of the delirium-score NuDESC (Nursing Delirium Screening Scale) and compare the results with the acetylcholinesterase activity, butyrylcholinesterase activity and the serum anticholinergic activity (SAA) at corresponding time points.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date July 2014
Est. primary completion date July 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Signed written informed consent

- Elective surgery

Exclusion Criteria:

- Preexisting psychiatric or neurological disease

- No surgery

- Reduced level of consciousness

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Germany University of Heidelberg Heidelberg

Sponsors (1)
Lead Sponsor Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary change of acetylcholinesterase (U/l) change of acetylcholinesterase in units per litre one day before surgery, 1-24h after surgery, 25-72h after surgery
Secondary change of NuDESC change of nursing delirium screening score one day before surgery, 1-24h after surgery, 25-72h after surgery
Secondary change of medication change of medication, that could influence a delirium one day before surgery, 1-24h after surgery, 25-72h after surgery
Secondary ICD-codes of main disease International classification of diseases-code of main disease 25-72h after surgery
Secondary ICD-codes of coexisting diseases International classification of diseases-codes of coexisting diseases 25-72h after surgery
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