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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02505815
Other study ID # 2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2014
Est. completion date September 2016

Study information

Verified date December 2020
Source University of Erlangen-Nürnberg Medical School
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Postoperative cognitive dysfunction (POCD) is a disease with restricted cognitive memory function and intellectual skills, which occurs after surgery with and without anesthesia. The POCD strongly depends on patient's age and the surgical operation type. The anesthesia procedure plays a pivotal role as well and regarding the current knowledge it is still uncertain which technique matches the lowest risk. Elevated stress level accompanied with regional anesthesia procedures are accused to cause POCD in elderly patients. The investigators address the question weather regional or general anesthesia leads to a pronounced POCD in dependence of stress incidence.


Description:

Postoperative cognitive dysfunction (POCD) is a disease with restricted cognitive memory function and intellectual skills, which occurs after surgery with and without anesthesia. The limiting cognitive ability leads to a lack of quality of life for a lot of patients. The POCD strongly depends on patient's age and the surgical operation type. In aged adults the incidence of POCD after one week following surgery is 25,8%. Risk factors for the development of a POCD is beside age less education and a reduced cognitive reserve. However, the anesthesia procedure plays a pivotal role as well and regarding the current knowledge it is still uncertain which technique matches the lowest risk. Elevated stress level accompanied with regional anesthesia procedures are accused to cause POCD in elderly patients. This fact leads to the question if a general anesthesia technique has a lower stress level and consequently leads to a reduced risk for a POCD development. Likewise the investigators address this hypothesis and analyze cognitive function following both anesthesia techniques separately in elderly patients.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date September 2016
Est. primary completion date September 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 85 Years
Eligibility Inclusion Criteria: - Patients within 50-85 years of age both gender. Exclusion Criteria: - Patients under 50 years of age or older than 85 years of age. - Preexisting neurological, neuropsychological deficits or diseases, e.g. cerebral insult or epilepsy. - Preexisting neurological, neuropsychological medication, preexisting neuromuscular diseases. - Alcohol- and drug abuse. Postoperative complications, pain and time shifts within the test protocol.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Surgery

Cortisol Level Measurement

Neurocognitive Testing


Locations

Country Name City State
Germany University Hospital Erlangen, Dept. Anaesthesiology Erlangen Bavaria

Sponsors (1)

Lead Sponsor Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Neurocognitive Function Using different tests addressing a various quality of neurocognitive function (attention, memory, perceptual and processing speed, alertness and executive function) participants score test appropriate values. Comparing test values separately allows to distinguish between prior - and post - operative status. Moreover it allows to discriminate achieved test results between both groups and calculate statistical differences. Favorable test results lead to a potential better neurocognitive function outcome and enable to assess neurocognitive function in the light of operation consequence. 5 Days
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