Postoperative Cognitive DysfunctionNCT03620968
Implementation of a Cognitive Training Program to Reduce the Risk of Postoperative Cognitive Dysfunction
A study testing cognitive training in people with Postoperative Cognitive Dysfunction, run by Centro Medico Teknon at 1 site in Spain.
Trial summary
Background: The postoperative cognitive dysfunction (POCD) is a frequent complication, often underestimated and leads to a negative impact on the quality of life for patients and their families. Read more about this study
- Who is it for?
- Ages 55 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Cognitive Dysfunction
- What is being tested?
- cognitive training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteSpain
- Study dates
- 10 Sep 2018to 21 Jan 2022
- Phase
- Interventional
- 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 55 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >55y <70y
- Patients ASA I, II, II
- Medium or high surgical complexity
Who cannot join
- <55y
- previous surgery less than 6 month ago
- psychiatric disease
- Neurological disease
- Brain tumors
- expected survival less than 3 month
- emergencies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Implementation of a Cognitive Training Program in the Elderly to Reduce the Risk of Postoperative Cognitive Dysfunction in Elective Non-cardiac Surgery "
Background: The postoperative cognitive dysfunction (POCD) is a frequent complication, often underestimated and leads to a negative impact on the quality of life for patients and their families.
Objective: Measure the effectiveness of the cognitive training in reducing POCD in patients 55 and 70 years old undergoing elective non cardiac surgery with a degree II-III (medium-high) in "Centro Médico Teknon" Barcelona, during 2017-2018.
Read more
Methodology: Randomized control clinical trial. The anticipate sample size is approximately 225, 75 in each group. Cognitive training performed at different stages of the perioperative period. Measure the cognitive function through a battery of neuropsychological tests during the preoperative (10 days pre-surgery) and postoperative (at 3 - 30 and 90 days post-surgery). Data analysis: SPSS 22, descriptive and inferential analysis: Chi-square, Student's t-test, ANOVA and Pearson correlation (p<0,05).
Limitations: Loss for non-intervention and loss of follow-up. Applicability: Strategy to improve the quality of life patients and reduce socioeconomic costs associated.
Read the detailed description
Postoperative Cognitive Dysfunction (PCD) is a frequent and serious complication associated with the surgical / anesthetic act. It is an under-recognized and underestimated entity, as it can often go unnoticed even though its effects can be devastating. The cognitive domains affected are diverse and can include memory, perception, verbal abilities and executive functions.
It is not the only postoperative cognitive disorder and for this reason it is important not to confuse it with delirium and dementia. Cognitive dysfunction still does not have a diagnostic code formally defined by ICD-10 (International Classification of Disease) or by the DSM-V, although the medical field has begun to use this term for the general description of those patients who complain about memory alterations and the thought process in the postoperative period. Its detection and evaluation depend on the comparative analysis of the cognitive function (analyzed by means of neuropsychological tests) betinestigatorsen the pre and postoperative period. It is considered, in most of the cases, a mild or moderate cognitive impairment of a transient and reversible nature. Its etiology is unknown, and it is related to a complex and multifactorial pathophysiology. The most accepted physiopathological hypothesis is the inflammatory alteration of the Central nervous system (neuroinflammation) due to surgical trauma, with the consequent deterioration of the cognitive reserve contributing to a cognitive deficit. At the present moment there is no effective strategy tested to prevent PCD.
Some of the most relevant studies on this disorder inestigatorsre published in The Lancet in 1998 (Moller et al.) and Anesthesiology in 2008 (Monk et al.). These studies determined that surgery and anesthesia caused PCD in the long term. They also concluded that the PCD appears in all ages but that old age exponentially increases the risk of suffering it. In addition, a low educational level increases the risk of PCD and people who maintain a PCD after 3 months, are more likely to experience dementia and a higher mortality risk in the first year after surgery.
The relevant impact of this disorder is dependent on an increase in mortality, a workforce loss due to incapacity and early retirement, and social cost due to sick leave, medical and nursing homes for the, now dependent, patient.
At present, it is important to identify, create and evaluate procedures aimed at helping patients at risk from this disorder from anesthesia consultations, as a way to help improve the outcomes. In this sense, this project proposes the validation of cognitive training as a non-pharmacological intervention to reduce incidence and intensity of Postoperative Cognitive Dysfunction.
This intervention is based on the fact that an increase in the neurological functional reserve could serve as a protective factor against cognitive dysfunction, improving plasticity and brain reserve and subsequently improving the performance of mental capacities, through organized techniques and exercises before surgery. It is proposed as the first non-pharmacological intervention in cases of normal aging, mild cognitive impairment and slight dementia. In addition, it´s low cost and has no significant negative effects.
Therefore, inestigators propose a cognitive training APP, developed by Spanish Neuropsychologists aimed at improving cognitive functions, that can be accessed from an online platform meant for practitioners to oversee patient development.
Main objective: Measure the effectiveness and impact of the cognitive training program "Sincrolab" on Postoperative Cognitive Dysfunction in patients aged 55-70 years, after elective, non-cardiac, degree-II-III complexity (mid-high), surgery, in Centro Médico Teknon, Barcelona, betinestigatorsen 2019-2020
Specific objectives:
- Measure the incidence of PCD in different study groups at 3 days, 1 month and 3 months of the surgical procedure.
- Compare the evolution of PCD in the intervention group and the control group.
- Measure the duration and intensity of the PCD in the different study groups.
- Identify the development of PCD in relation to: age, sex, the type of surgical intervention, duration of surgery, types of anesthesia, postoperative complication.
- Measure the adherence to the proposed cognitive training pattern, determining the rate of drop-outs.
Study Hypothesis The implementation of a cognitive training program during the perioperative period decreases the incidence, intensity and duration of Postoperative Cognitive Dysfunction.
Design of the study:
It is an epidemiological study, located in the empirical-analytic paradigm, that intends to obtain knowledge objectively identifying, the cause-effect relationships betinestigatorsen cognitive training during the perioperative and the development of PCD, by studying memory alterations and executive functions. It's a pre-test/post-test experimental study design, with random allocation, and the creation of 3 study groups:
- Control group: no cognitive training
- Experimental Group 1: Cognitive Training program 10 days prior to surgery.
- Experimental Group 2: Cognitive Training program 10 days prior to surgery continuing for over a inestigatorsek after surgery.
The evaluation of the cognitive function will be carried out following the same protocol for all the three groups and will take place at different times of the perioperative period, initially on the preanesthesia visit to set a baseline, and later on the postoperative period at 3 days, 1 month and 3 month post-surgery.
Study population:
Men and women, ASA I-III, betinestigatorsen 55-70 years of age who are visited in the pre-anesthesia clinic, and scheduled for elective, noncardiac surgery, understand the purpose of the study, sign informed consent and meet the selection criteria.
Variables:
Independent: Cognitive training, through the computer application "Sincrolab". Dependent: Development of PCD, measured through the application of a neuropsychological test battery that test the cognitive domain of memory and executive functions.
The implementation of an effective program for screening, prevention and treatment of the PCD, can have a direct impact on patient safety, improve outcomes of surgical interventions and help in maintaining quality of life and active role in society of our older patients.
With the aging of the population, PCD is a problem that will become increasingly important to measure, and inestigators can imagine a multidisciplinary approach to be necessary since a patient disabled by PCD is a health problem with important economic and social connotations. Therefore, the preservation of the brain's functional and cognitive capacities deserves all of our attention and interest.
- Conditions
- Postoperative Cognitive Dysfunction
- Being tested
- cognitive training
- Keywords
- Postoperative cognitive dysfunction, Cognitive training, Anaesthesia in Non-cardiac surgery, Elderly adult, Perioperative management.
- Medical subject headings
- Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive trainingOther
15 minutes day of brain training by an APP
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | No intervention | Control, no intervention |
| Group 2 | Experimental | Intervention before surgery (cognitive training) Receives: Other: cognitive training |
| Group 3 | Experimental | Intervention Before and after surgery (cognitive training) Receives: Other: cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the effectiveness of a cognitive training program on the post op cognitive dysfunction
Impact of a training program on the cognitive dysfunction measured with: Mini-cog test for. Scale: 0-5, normal values > 3; measurements at 3 days, 1 month and 3 month after surgery
Measured: 3 months
Secondary outcomes (9)
Impact of a training program on the memory alterations
Impact of a training program on the memory alterations measured with T@M test. Scale: 0-50. normal values > 35 and < 5 minutes execution test time.; measurements at 3 days, 1 month and 3 month after surgery
Measured: 3month
Impact of a training program on the alteration of the daily memory
Impact of a training program on the alteration of the daily memory measured with test: MFE Test for evaluation of the daily memory. Scale 0-84. normal values: Variations < 20%; measurements at 3 days, 1 month and 3 month after surgery
Measured: 3 month
Impact of a training program on the alterations of anxiety and depression
Impact of a training program on the alterations of anxiety and depression measured with Goldberg Test. Anxiety scale: 0-9, normal values < 5, Depression scale: 0-9, normal values <3; measurements at 3 days, 1 month and 3 month after surgery
Measured: 3 month
Measure the development of PCD in the different patient groups in relation of age
Measure the development of the PCD in the different patient groups in relation of the age of the patient. Measured in the different study areas: cognitive, memory, daily memory, anxiety and depression.
Measured: 3 month
Measure the development of PCD in relation of sex in the different patient groups
Measure the development of the PCD in the different patient groups in relation of sex of the patient. Measured in the different study areas: cognitive, memory, daily memory, anxiety and depression
Measured: 3 month
Measure the development of PCD in relation of duration of surgery in the different patient groups
Measure the development of the PCD in the different patient groups in relation of the duration of the surgery. Measured in the different study areas: cognitive, memory, daily memory, anxiety and depression
Measured: 3 month
Measure the development of PCD in relation of anesthesia technique in the diferent patient group
Measure the development of the PCD in the different patient groups in relation of the type of anesthesia. General intravenous anesthesia, general inhalatory anesthesia, regional anesthesia. Measured in the different study areas: cognitive, memory, daily memory, anxiety and depression
Measured: 3 month
Measure the development of PCD in relation of type of post operative complications, in the different patient gruops
Measure the development of the PCD in the different patient groups in relation of the post-operative complications. Measured in the different study areas: cognitive, memory, daily memory, anxiety and depression
Measured: 3 month
Adherence to the cognitive training program
Assessment of the adherence to the proposed cognitive training, determining the rate of drop-outs in the PCD
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start10 Sep 2018
- Primary completion20 Jan 2021
- Study completion21 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Postoperative Cognitive DysfunctionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Medico Teknon
- Sponsor type
- University, hospital or other
- Collaborators
- University of Barcelona
- Responsible party
- Principal investigator, Bibiana Ros Nebot, Centro Medico Teknon
- Investigators
- Josep Rodiera Olivé, MD.Ph., Study director, Centro Medico Teknon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03620968
- Sponsor's protocol ID
- DCPO2017
- Status last verified
- Mar 2022
- First submitted
- 26 Dec 2017
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Steinmetz J, Rasmussen LS. Peri-operative cognitive dysfunction and protection. Anaesthesia. 2016 Jan;71 Suppl 1:58-63. doi: 10.1111/anae.13308.
PubMed 26620148Scott JE, Mathias JL, Kneebone AC. Postoperative cognitive dysfunction after total joint arthroplasty in the elderly: a meta-analysis. J Arthroplasty. 2014 Feb;29(2):261-7.e1. doi: 10.1016/j.arth.2013.06.007. Epub 2013 Jul 23.
PubMed 23890520Fong TG, Hshieh TT, Wong B, Tommet D, Jones RN, Schmitt EM, Puelle MR, Saczynski JS, Marcantonio ER, Inouye SK. Neuropsychological profiles of an elderly cohort undergoing elective surgery and the relationship between cognitive performance and delirium. J Am Geriatr Soc. 2015 May;63(5):977-82. doi: 10.1111/jgs.13383. Epub 2015 May 4.
PubMed 25944109Monk TG, Weldon BC, Garvan CW, Dede DE, van der Aa MT, Heilman KM, Gravenstein JS. Predictors of cognitive dysfunction after major noncardiac surgery. Anesthesiology. 2008 Jan;108(1):18-30. doi: 10.1097/01.anes.0000296071.19434.1e.
PubMed 18156878Kawano T, Eguchi S, Iwata H, Tamura T, Kumagai N, Yokoyama M. Impact of Preoperative Environmental Enrichment on Prevention of Development of Cognitive Impairment following Abdominal Surgery in a Rat Model. Anesthesiology. 2015 Jul;123(1):160-70. doi: 10.1097/ALN.0000000000000697.
PubMed 26001032Shu AH, Wang Q, Chen XB. Effect of different depths of anesthesia on postoperative cognitive function in laparoscopic patients: a randomized clinical trial. Curr Med Res Opin. 2015;31(10):1883-7. doi: 10.1185/03007995.2015.1075968. Epub 2015 Sep 4.
PubMed 26202165Ballard C, Jones E, Gauge N, Aarsland D, Nilsen OB, Saxby BK, Lowery D, Corbett A, Wesnes K, Katsaiti E, Arden J, Amoako D, Prophet N, Purushothaman B, Green D. Optimised anaesthesia to reduce post operative cognitive decline (POCD) in older patients undergoing elective surgery, a randomised controlled trial. PLoS One. 2012;7(6):e37410. doi: 10.1371/journal.pone.0037410. Epub 2012 Jun 15.
PubMed 22719840Saleh AJ, Tang GX, Hadi SM, Yan L, Chen MH, Duan KM, Tong J, Ouyang W. Preoperative cognitive intervention reduces cognitive dysfunction in elderly patients after gastrointestinal surgery: a randomized controlled trial. Med Sci Monit. 2015 Mar 17;21:798-805. doi: 10.12659/MSM.893359.
PubMed 25782136
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Implementation of a Cognitive Training Program in the Elderly to Reduce the Risk of Postoperative Cognitive Dysfunction in Elective Non-cardiac Surgery "
- ClinicalTrials.gov ID
- NCT03620968
- Acronym / sponsor ID
- DCPO2017
- Conditions
- Postoperative Cognitive Dysfunction
- Keywords
- Postoperative cognitive dysfunction, Cognitive training, Anaesthesia in Non-cardiac surgery, Elderly adult, Perioperative management.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Centro Medico TeknonUniversity, hospital or other
- Collaborators
- University of Barcelona
- Study start
- 10 Sep 2018 (actual)
- Primary completion
- 20 Jan 2021 (actual)
- Study completion
- 21 Jan 2022 (actual)
- First posted
- 8 Aug 2018 (actual)
- 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.
Background: The postoperative cognitive dysfunction (POCD) is a frequent complication, often underestimated and leads to a negative impact on the quality of life for patients and their families.
Objective: Measure the effectiveness of the cognitive training in reducing POCD in patients 55 and 70 years old undergoing elective non cardiac surgery with a degree II-III (medium-high) in "Centro Médico Teknon" Barcelona, during 2017-2018.
Methodology: Randomized control clinical trial. The anticipate sample size is approximately 225, 75 in each group. Cognitive training performed at different stages of the perioperative period. Measure the cognitive function through a battery of neuropsychological tests during the preoperative (10 days pre-surgery) and postoperative (at 3 - 30 and 90 days post-surgery). Data analysis: SPSS 22, descriptive and inferential analysis: Chi-square, Student's t-test, ANOVA and Pearson correlation (p<0,05).
Limitations: Loss for non-intervention and loss of follow-up. Applicability: Strategy to improve the quality of life patients and reduce socioeconomic costs associated.
Detailed description
Postoperative Cognitive Dysfunction (PCD) is a frequent and serious complication associated with the surgical / anesthetic act. It is an under-recognized and underestimated entity, as it can often go unnoticed even though its effects can be devastating. The cognitive domains affected are diverse and can include memory, perception, verbal abilities and executive functions.
It is not the only postoperative cognitive disorder and for this reason it is important not to confuse it with delirium and dementia. Cognitive dysfunction still does not have a diagnostic code formally defined by ICD-10 (International Classification of Disease) or by the DSM-V, although the medical field has begun to use this term for the general description of those patients who complain about memory alterations and the thought process in the postoperative period. Its detection and evaluation depend on the comparative analysis of the cognitive function (analyzed by means of neuropsychological tests) betinestigatorsen the pre and postoperative period. It is considered, in most of the cases, a mild or moderate cognitive impairment of a transient and reversible nature. Its etiology is unknown, and it is related to a complex and multifactorial pathophysiology. The most accepted physiopathological hypothesis is the inflammatory alteration of the Central nervous system (neuroinflammation) due to surgical trauma, with the consequent deterioration of the cognitive reserve contributing to a cognitive deficit. At the present moment there is no effective strategy tested to prevent PCD.
Some of the most relevant studies on this disorder inestigatorsre published in The Lancet in 1998 (Moller et al.) and Anesthesiology in 2008 (Monk et al.). These studies determined that surgery and anesthesia caused PCD in the long term. They also concluded that the PCD appears in all ages but that old age exponentially increases the risk of suffering it. In addition, a low educational level increases the risk of PCD and people who maintain a PCD after 3 months, are more likely to experience dementia and a higher mortality risk in the first year after surgery.
The relevant impact of this disorder is dependent on an increase in mortality, a workforce loss due to incapacity and early retirement, and social cost due to sick leave, medical and nursing homes for the, now dependent, patient.
At present, it is important to identify, create and evaluate procedures aimed at helping patients at risk from this disorder from anesthesia consultations, as a way to help improve the outcomes. In this sense, this project proposes the validation of cognitive training as a non-pharmacological intervention to reduce incidence and intensity of Postoperative Cognitive Dysfunction.
This intervention is based on the fact that an increase in the neurological functional reserve could serve as a protective factor against cognitive dysfunction, improving plasticity and brain reserve and subsequently improving the performance of mental capacities, through organized techniques and exercises before surgery. It is proposed as the first non-pharmacological intervention in cases of normal aging, mild cognitive impairment and slight dementia. In addition, it´s low cost and has no significant negative effects.
Therefore, inestigators propose a cognitive training APP, developed by Spanish Neuropsychologists aimed at improving cognitive functions, that can be accessed from an online platform meant for practitioners to oversee patient development.
Main objective: Measure the effectiveness and impact of the cognitive training program "Sincrolab" on Postoperative Cognitive Dysfunction in patients aged 55-70 years, after elective, non-cardiac, degree-II-III complexity (mid-high), surgery, in Centro Médico Teknon, Barcelona, betinestigatorsen 2019-2020
Specific objectives:
- Measure the incidence of PCD in different study groups at 3 days, 1 month and 3 months of the surgical procedure.
- Compare the evolution of PCD in the intervention group and the control group.
- Measure the duration and intensity of the PCD in the different study groups.
- Identify the development of PCD in relation to: age, sex, the type of surgical intervention, duration of surgery, types of anesthesia, postoperative complication.
- Measure the adherence to the proposed cognitive training pattern, determining the rate of drop-outs.
Study Hypothesis The implementation of a cognitive training program during the perioperative period decreases the incidence, intensity and duration of Postoperative Cognitive Dysfunction.
Design of the study:
It is an epidemiological study, located in the empirical-analytic paradigm, that intends to obtain knowledge objectively identifying, the cause-effect relationships betinestigatorsen cognitive training during the perioperative and the development of PCD, by studying memory alterations and executive functions. It's a pre-test/post-test experimental study design, with random allocation, and the creation of 3 study groups:
- Control group: no cognitive training
- Experimental Group 1: Cognitive Training program 10 days prior to surgery.
- Experimental Group 2: Cognitive Training program 10 days prior to surgery continuing for over a inestigatorsek after surgery.
The evaluation of the cognitive function will be carried out following the same protocol for all the three groups and will take place at different times of the perioperative period, initially on the preanesthesia visit to set a baseline, and later on the postoperative period at 3 days, 1 month and 3 month post-surgery.
Study population:
Men and women, ASA I-III, betinestigatorsen 55-70 years of age who are visited in the pre-anesthesia clinic, and scheduled for elective, noncardiac surgery, understand the purpose of the study, sign informed consent and meet the selection criteria.
Variables:
Independent: Cognitive training, through the computer application "Sincrolab". Dependent: Development of PCD, measured through the application of a neuropsychological test battery that test the cognitive domain of memory and executive functions.
The implementation of an effective program for screening, prevention and treatment of the PCD, can have a direct impact on patient safety, improve outcomes of surgical interventions and help in maintaining quality of life and active role in society of our older patients.
With the aging of the population, PCD is a problem that will become increasingly important to measure, and inestigators can imagine a multidisciplinary approach to be necessary since a patient disabled by PCD is a health problem with important economic and social connotations. Therefore, the preservation of the brain's functional and cognitive capacities deserves all of our attention and interest.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | No intervention | –Control, no intervention |
| Group 2 | Experimental | Other: cognitive trainingIntervention before surgery (cognitive training) |
| Group 3 | Experimental | Other: cognitive trainingIntervention Before and after surgery (cognitive training) |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- >55y <70y
- Patients ASA I, II, II
- Medium or high surgical complexity
Key exclusion criteria (7 listed)
- <55y
- previous surgery less than 6 month ago
- psychiatric disease
- Neurological disease
- Brain tumors
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 |
|---|---|---|
| cognitive training15 minutes day of brain training by an APP | Other | Group 2, Group 3 |
Primary outcome
Measure the effectiveness of a cognitive training program on the post op cognitive dysfunction
Time frame: 3 months
Impact of a training program on the cognitive dysfunction measured with: Mini-cog test for. Scale: 0-5, normal values > 3; measurements at 3 days, 1 month and 3 month after surgery
9 secondary outcomes
Impact of a training program on the memory alterations
Time frame: 3month
Impact of a training program on the alteration of the daily memory
Time frame: 3 month
Impact of a training program on the alterations of anxiety and depression
Time frame: 3 month
Measure the development of PCD in the different patient groups in relation of age
Time frame: 3 month
Measure the development of PCD in relation of sex in the different patient groups
Time frame: 3 month
Measure the development of PCD in relation of duration of surgery in the different patient groups
Time frame: 3 month
Measure the development of PCD in relation of anesthesia technique in the diferent patient group
Time frame: 3 month
Measure the development of PCD in relation of type of post operative complications, in the different patient gruops
Time frame: 3 month
Adherence to the cognitive training program
Time frame: 3 month
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 10 Mar 2022.
- Background: PubMed 26620148Steinmetz J, Rasmussen LS. Peri-operative cognitive dysfunction and protection. Anaesthesia. 2016 Jan;71 Suppl 1:58-63. doi: 10.1111/anae.13308.
- Background: PubMed 23890520Scott JE, Mathias JL, Kneebone AC. Postoperative cognitive dysfunction after total joint arthroplasty in the elderly: a meta-analysis. J Arthroplasty. 2014 Feb;29(2):261-7.e1. doi: 10.1016/j.arth.2013.06.007. Epub 2013 Jul 23.
- Background: PubMed 25944109Fong TG, Hshieh TT, Wong B, Tommet D, Jones RN, Schmitt EM, Puelle MR, Saczynski JS, Marcantonio ER, Inouye SK. Neuropsychological profiles of an elderly cohort undergoing elective surgery and the relationship between cognitive performance and delirium. J Am Geriatr Soc. 2015 May;63(5):977-82. doi: 10.1111/jgs.13383. Epub 2015 May 4.
- Background: PubMed 18156878Monk TG, Weldon BC, Garvan CW, Dede DE, van der Aa MT, Heilman KM, Gravenstein JS. Predictors of cognitive dysfunction after major noncardiac surgery. Anesthesiology. 2008 Jan;108(1):18-30. doi: 10.1097/01.anes.0000296071.19434.1e.
- Background: PubMed 26001032Kawano T, Eguchi S, Iwata H, Tamura T, Kumagai N, Yokoyama M. Impact of Preoperative Environmental Enrichment on Prevention of Development of Cognitive Impairment following Abdominal Surgery in a Rat Model. Anesthesiology. 2015 Jul;123(1):160-70. doi: 10.1097/ALN.0000000000000697.
- Background: PubMed 26202165Shu AH, Wang Q, Chen XB. Effect of different depths of anesthesia on postoperative cognitive function in laparoscopic patients: a randomized clinical trial. Curr Med Res Opin. 2015;31(10):1883-7. doi: 10.1185/03007995.2015.1075968. Epub 2015 Sep 4.
- Background: PubMed 22719840Ballard C, Jones E, Gauge N, Aarsland D, Nilsen OB, Saxby BK, Lowery D, Corbett A, Wesnes K, Katsaiti E, Arden J, Amoako D, Prophet N, Purushothaman B, Green D. Optimised anaesthesia to reduce post operative cognitive decline (POCD) in older patients undergoing elective surgery, a randomised controlled trial. PLoS One. 2012;7(6):e37410. doi: 10.1371/journal.pone.0037410. Epub 2012 Jun 15.
- Background: PubMed 25782136Saleh AJ, Tang GX, Hadi SM, Yan L, Chen MH, Duan KM, Tong J, Ouyang W. Preoperative cognitive intervention reduces cognitive dysfunction in elderly patients after gastrointestinal surgery: a randomized controlled trial. Med Sci Monit. 2015 Mar 17;21:798-805. doi: 10.12659/MSM.893359.
- Individual participant dataSharing planned: No
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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.
Josep Rodiera Olivé, MD.Ph. study director
Centro Medico Teknon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive training in people with Postoperative Cognitive Dysfunction, run by Centro Medico Teknon at 1 site in Spain.
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 3 inclusion and 7 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 10 Mar 2022. 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 Spain. 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?
Measure the effectiveness of a cognitive training program on the post op cognitive dysfunction (time frame: 3 months). 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 NCT03620968, which also lists 8 linked publications.
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 10 Mar 2022.