Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06435247
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-05-24
Brief Title:
The Effect of Accompaniment by Older Adults on Anesthetic Recovery
Sponsor:
American British Cowdray Medical Center
Organization:
American British Cowdray Medical Center
Study Overview
Official Title:
The Effect of Accompaniment by Older Adults on Anaesthetic Recovery
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AAR
Brief Summary:
Summary
In 2022 Mexico estimated a population of 17958707 older adults With increased life expectancy it is essential to seek strategies that improve the health of this population as they are more vulnerable compared to other age groups due to functional and cognitive decline along with an increase in chronic diseases and medication intake During this stage of life there is a possibility of requiring surgical treatment which is the focus of this protocol proposing a maneuver that impacts patients health without requiring economic costs The proposal suggests the accompaniment of older adults by a family member during the immediate post-anesthetic period Hypothesis Accompaniment of older adults during the immediate postoperative period improves the quality of anesthetic recovery by 60 This value is based on a study by Shem where accompanying older adults prior to anesthetic induction resulted in a 61 reduction in anxiety among older adults Anesthesiologists have expanded their role in perioperative medicine alongside geriatric medicine services for older surgical patients
An experimental study will be conducted with two randomly divided groups one group with accompaniment and one group without accompaniment in the recovery area Both groups will be assessed using different questionnaires 1 Pfeiffer Test for cognitive impairment diagnosis 2 QoR-15 to assess the quality of anesthetic recovery 3 Beck Anxiety Questionnaire all of which will be administered 24 hours after surgery Delirium will also be assessed using NuDESC at 24 hours day 5 and 30 days after surgery General data prior to surgery will be recorded and vital signs such as heart rate blood pressure and pain on a verbal scale from 0 to 10 will be monitored during the postoperative period
Statistical analysis will involve representing baseline characteristics of the population using mean and standard deviation or median and interquartile range depending on the distribution type X2 will be used to compare both groups in terms of outcomes Finally a multivariate analysis will be conducted using logistic regression to adjust for confounding variables
In 2022 Mexico estimated a population of 17958707 older adults With increased life expectancy it is essential to seek strategies that improve the health of this population as they are more vulnerable compared to other age groups due to functional and cognitive decline along with an increase in chronic diseases and medication intake During this stage of life there is a possibility of requiring surgical treatment which is the focus of this protocol proposing a maneuver that impacts patients health without requiring economic costs The proposal suggests the accompaniment of older adults by a family member during the immediate post-anesthetic period Hypothesis Accompaniment of older adults during the immediate postoperative period improves the quality of anesthetic recovery by 60 This value is based on a study by Shem where accompanying older adults prior to anesthetic induction resulted in a 61 reduction in anxiety among older adults Anesthesiologists have expanded their role in perioperative medicine alongside geriatric medicine services for older surgical patients
An experimental study will be conducted with two randomly divided groups one group with accompaniment and one group without accompaniment in the recovery area Both groups will be assessed using different questionnaires 1 Pfeiffer Test for cognitive impairment diagnosis 2 QoR-15 to assess the quality of anesthetic recovery 3 Beck Anxiety Questionnaire all of which will be administered 24 hours after surgery Delirium will also be assessed using NuDESC at 24 hours day 5 and 30 days after surgery General data prior to surgery will be recorded and vital signs such as heart rate blood pressure and pain on a verbal scale from 0 to 10 will be monitored during the postoperative period
Statistical analysis will involve representing baseline characteristics of the population using mean and standard deviation or median and interquartile range depending on the distribution type X2 will be used to compare both groups in terms of outcomes Finally a multivariate analysis will be conducted using logistic regression to adjust for confounding variables
Detailed Description:
Justification
Due to the increase in life expectancy and the growing number of older adults worldwide and in our country it is important to search for and implement feasible and cost-free measures to improve the quality of medical care specifically in surgical treatments that impact the reduction of complications shorten recovery time and indirectly improve the quality of life for these patients
Feasibility and relevance
The research question aims to improve the quality of medical care for older adults with a humanistic approach
In a group of people that will continue to grow with a longer life expectancy they will require surgical treatments
There are no articles evaluating the quality of anesthetic recovery or its impact on their health with accompaniment
Approximately 222 surgeries are performed in this population every month making it a frequent occurrence
It is a measure that does not incur any cost
It can be applied in any hospital setting
Problem statement
The increase in life expectancy worldwide has led to a larger population of older adults and Mexico is no exception Therefore it is important to establish measures that improve the quality of medical care and reduce complications in this age group using measures that do not incur any economic costs Specifically in the perioperative period proposing the accompaniment of older adults in the anesthetic recovery area
Research question
Does the accompaniment of older adults improve the quality of anesthetic recovery with a score higher than 122 on the QoR15 quality of recovery - 15 scale
Hypotheses
Null hypothesis
The accompaniment of older adults in the immediate postoperative period does not improve the quality of anesthetic recovery with a score lower than 121 on the QoR15 scale
Alternative hypothesis
The accompaniment of older adults in the immediate postoperative period improves the quality of anesthetic recovery with a score higher than 122 on the QoR15 scale
Overall objective
- Determine if the accompaniment of older adults improves the quality of anesthetic recovery classified as good or excellent according to the QoR15 scale with a score of 122 to 150
Specific objectives
Determine the incidence of anxiety in older adults in the anesthetic recovery area considering anxiety with a score higher than 22 on the Beck scale
Determine the presence or absence of delirium in older adults in the perioperative period
Assess if the accompaniment of older adults reduces the length of stay in the anesthetic recovery area aiming for a stay of no more than 60 minutes
Due to the increase in life expectancy and the growing number of older adults worldwide and in our country it is important to search for and implement feasible and cost-free measures to improve the quality of medical care specifically in surgical treatments that impact the reduction of complications shorten recovery time and indirectly improve the quality of life for these patients
Feasibility and relevance
The research question aims to improve the quality of medical care for older adults with a humanistic approach
In a group of people that will continue to grow with a longer life expectancy they will require surgical treatments
There are no articles evaluating the quality of anesthetic recovery or its impact on their health with accompaniment
Approximately 222 surgeries are performed in this population every month making it a frequent occurrence
It is a measure that does not incur any cost
It can be applied in any hospital setting
Problem statement
The increase in life expectancy worldwide has led to a larger population of older adults and Mexico is no exception Therefore it is important to establish measures that improve the quality of medical care and reduce complications in this age group using measures that do not incur any economic costs Specifically in the perioperative period proposing the accompaniment of older adults in the anesthetic recovery area
Research question
Does the accompaniment of older adults improve the quality of anesthetic recovery with a score higher than 122 on the QoR15 quality of recovery - 15 scale
Hypotheses
Null hypothesis
The accompaniment of older adults in the immediate postoperative period does not improve the quality of anesthetic recovery with a score lower than 121 on the QoR15 scale
Alternative hypothesis
The accompaniment of older adults in the immediate postoperative period improves the quality of anesthetic recovery with a score higher than 122 on the QoR15 scale
Overall objective
- Determine if the accompaniment of older adults improves the quality of anesthetic recovery classified as good or excellent according to the QoR15 scale with a score of 122 to 150
Specific objectives
Determine the incidence of anxiety in older adults in the anesthetic recovery area considering anxiety with a score higher than 22 on the Beck scale
Determine the presence or absence of delirium in older adults in the perioperative period
Assess if the accompaniment of older adults reduces the length of stay in the anesthetic recovery area aiming for a stay of no more than 60 minutes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None