Neurocognitive Function245_14_BNCT02505815
Neurocognitive Function After Regional and General Anesthesia (245_14 B)
An observational study of Neurocognitive Function, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurocognitive Function
- What is being tested?
- Surgery, Cortisol Level Measurement and Neurocognitive Testing
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2014to Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients recruted at the University Hospital Erlangen prior surgery. Anesthesia procedure eigther in regional or general manner.
Who may be able to join
- Patients within 50-85 years of age both gender.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Erlangen, Dept. Anaesthesiology
Erlangen, Bavaria, 91054
About this study
Official title: 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.
Read the 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.
- Conditions
- Neurocognitive Function
- Being tested
- Surgery, Cortisol Level Measurement, Neurocognitive Testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
Cortisol Level MeasurementProcedure or surgery
Neurocognitive TestingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Regional Anesthesia | Patients with surgery in regional anesthesia. Receives: Procedure: Surgery; Procedure: Cortisol Level Measurement; Procedure: Neurocognitive Testing | |
| General Anesthesia | Patients with surgery in general anesthesia. Receives: Procedure: Surgery; Procedure: Cortisol Level Measurement; Procedure: Neurocognitive Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startSep 2014
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neurocognitive FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02505815
- Sponsor's protocol ID
- 2
- Acronym
- 245_14_B
- Status last verified
- Dec 2020
- First submitted
- 11 Jun 2015
- Last updated
- 11 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Wagner S, Breitkopf M, Ahrens E, Ma H, Kuester O, Thomas C, von Arnim CAF, Walther A. Cognitive function in older patients and their stress challenge using different anesthesia regimes: a single center observational study. BMC Anesthesiol. 2023 Jan 6;23(1):6. doi: 10.1186/s12871-022-01960-7.
PubMed 36609226
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurocognitive Function After Regional and General Anesthesia: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02505815
- Acronym / sponsor ID
- 245_14_B / 2
- Conditions
- Neurocognitive Function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 22 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regional Anesthesia | – | Procedure: Surgery, Procedure: Cortisol Level Measurement, Procedure: Neurocognitive TestingPatients with surgery in regional anesthesia. |
| General Anesthesia | – | Procedure: Surgery, Procedure: Cortisol Level Measurement, Procedure: Neurocognitive TestingPatients with surgery in general anesthesia. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients recruted at the University Hospital Erlangen prior surgery. Anesthesia procedure eigther in regional or general manner.
Key inclusion criteria (1 listed)
- Patients within 50-85 years of age both gender.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgery | Procedure or surgery | General Anesthesia, Regional Anesthesia |
| Cortisol Level Measurement | Procedure or surgery | General Anesthesia, Regional Anesthesia |
| Neurocognitive Testing | Procedure or surgery | General Anesthesia, Regional Anesthesia |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2020.
- Derived from this study: PubMed 36609226Wagner S, Breitkopf M, Ahrens E, Ma H, Kuester O, Thomas C, von Arnim CAF, Walther A. Cognitive function in older patients and their stress challenge using different anesthesia regimes: a single center observational study. BMC Anesthesiol. 2023 Jan 6;23(1):6. doi: 10.1186/s12871-022-01960-7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurocognitive Function, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurocognitive Function (time frame: 5 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02505815, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2020.