Neurocognitive Function Clinical Trial
— 245_14_BOfficial title:
Neurocognitive Function After Regional and General Anesthesia: a Randomized Control Trial
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 |
Verified date | December 2020 |
Source | University of Erlangen-Nürnberg Medical School |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Germany | University Hospital Erlangen, Dept. Anaesthesiology | Erlangen | Bavaria |
Lead Sponsor | Collaborator |
---|---|
University of Erlangen-Nürnberg Medical School |
Germany,
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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