Neurocognitive Function After Regional and General Anesthesia (245_14 B) (245_14_B)
December 10, 2020 updated by: University of Erlangen-Nürnberg Medical School
Neurocognitive Function After Regional and General Anesthesia: a Randomized Control Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Observational
Enrollment (Actual)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bavaria
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Erlangen, Bavaria, Germany, 91054
- University Hospital Erlangen, Dept. Anaesthesiology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients recruted at the University Hospital Erlangen prior surgery.
Anesthesia procedure eigther in regional or general manner.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Regional Anesthesia
Patients with surgery in regional anesthesia.
|
|
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General Anesthesia
Patients with surgery in general anesthesia.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neurocognitive Function
Time Frame: 5 Days
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2014
Primary Completion (Actual)
September 1, 2016
Study Completion (Actual)
September 1, 2016
Study Registration Dates
First Submitted
June 11, 2015
First Submitted That Met QC Criteria
July 20, 2015
First Posted (Estimate)
July 22, 2015
Study Record Updates
Last Update Posted (Actual)
December 11, 2020
Last Update Submitted That Met QC Criteria
December 10, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2 (Instituto Cardiovascular de Buenos Aires)
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