NCT03620968

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
225

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 26, 2017

Completed
8 months until next milestone

First Posted

Study publicly available on registry

August 8, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

September 10, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2022

Completed
Last Updated

March 10, 2022

Status Verified

March 1, 2022

Enrollment Period

2.4 years

First QC Date

December 26, 2017

Last Update Submit

March 8, 2022

Conditions

Postoperative Cognitive Dysfunction

Keywords

Postoperative cognitive dysfunctionCognitive trainingAnaesthesia in Non-cardiac surgeryElderly adultPerioperative management.

Outcome Measures

Primary Outcomes (1)

  • 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

    3 months

Secondary Outcomes (9)

  • Impact of a training program on the memory alterations

    3month

  • Impact of a training program on the alteration of the daily memory

    3 month

  • Impact of a training program on the alterations of anxiety and depression

    3 month

  • Measure the development of PCD in the different patient groups in relation of age

    3 month

  • Measure the development of PCD in relation of sex in the different patient groups

    3 month

  • +4 more secondary outcomes

Study Arms (3)

Group 1

NO INTERVENTION

Control, no intervention

Group 2

EXPERIMENTAL

Intervention before surgery (cognitive training)

Other: cognitive training

Group 3

EXPERIMENTAL

Intervention Before and after surgery (cognitive training)

Other: cognitive training

Interventions

cognitive trainingOTHER

15 minutes day of brain training by an APP

Group 2Group 3

Eligibility Criteria

Age55 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>55y \<70y
  • Patients ASA I, II, II
  • Medium or high surgical complexity

You may not qualify if:

  • \<55y
  • previous surgery less than 6 month ago
  • psychiatric disease
  • Neurological disease
  • Brain tumors
  • expected survival less than 3 month
  • emergencies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Medico Teknon, Servei d'anestesiologia

Barcelona, 08022, Spain

Location

Related Publications (8)

  • Steinmetz J, Rasmussen LS. Peri-operative cognitive dysfunction and protection. Anaesthesia. 2016 Jan;71 Suppl 1:58-63. doi: 10.1111/anae.13308.

    PMID: 26620148BACKGROUND

  • Scott 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.

    PMID: 23890520BACKGROUND

  • Fong 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.

    PMID: 25944109BACKGROUND

  • Monk 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.

    PMID: 18156878BACKGROUND

  • Kawano 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.

    PMID: 26001032BACKGROUND

  • Shu 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.

    PMID: 26202165BACKGROUND

  • Ballard 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.

    PMID: 22719840BACKGROUND

  • Saleh 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.

    PMID: 25782136BACKGROUND

MeSH Terms

Conditions

Postoperative Cognitive Complications

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsCognitive DysfunctionCognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Josep Rodiera Olivé, MD.Ph.

    Centro Medico Teknon

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSN, RN Anesthesia Nurse

Study Record Dates

First Submitted

December 26, 2017

First Posted

August 8, 2018

Study Start

September 10, 2018

Primary Completion

January 20, 2021

Study Completion

January 21, 2022

Last Updated

March 10, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)