ElderlyAARNCT06435247
The Effect of Accompaniment by Older Adults on Anesthetic Recovery
A study testing With or without accompaniment in the recovery anaesthetic area in people with Elderly and Anesthesia; Reaction, run by American British Cowdray Medical Center at 2 sites in Mexico.
Trial summary
Summary: In 2022, Mexico estimated a population of 17,958,707 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… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Elderly, Anesthesia; Reaction
- What is being tested?
- With or without accompaniment in the recovery anaesthetic area
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 2 sitesMexico
- Study dates
- 1 Jul 2024to Dec 2025
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- History of diseasses associated with dementia
- Emergency surgery.
- Regional anesthesia or sedation
- Moderate to severe cognitive impairment
- History of smoking or drugs
- Surgerios with risk of major bleeding more or equal 1000ml
- Hip or long bone surgeries
Trial locations and contacts
2 sites in 1 country.
Juan Talavera, consultant contact
Mexico2 sites, 2 recruiting
- Recruiting
El Centro Médico American Brithish Cowdray, I.A.P
Mexico City, 01120
Mariana Garcia, Investigador, +525541922325, mariana.26_11@hotmail.com
Juan Talavera, consultor, jotalaverap@abchospital.com
- Recruiting
Centro Médico ABC
Mexico City, 05348
García, mariana.26_11@hotmail.com
About this study
Official title: The Effect of Accompaniment by Older Adults on Anaesthetic Recovery
Summary:
In 2022, Mexico estimated a population of 17,958,707 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.
Read more
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.
Read the 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.
- Conditions
- Elderly, Anesthesia; Reaction
- Being tested
- With or without accompaniment in the recovery anaesthetic area
- Keywords
- ancianos, añadir la calidad de la recuperación anestésica, añadir acompañamiento
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
With or without accompaniment in the recovery anaesthetic areaBehavioural
one grup will have family accompaniment in the recovery area and the other group will not in both groups the QoR15 scale will be used to measure the quality of anesthetic recovery
| Study group | Role | What they receive |
|---|---|---|
| Accompaniment in the recovery area | Experimental | The first group will have a family member accompany them in the recovery area Receives: Behavioral: With or without accompaniment in the recovery anaesthetic area |
| without accompaniment | No intervention | The second group will not have accompaniment as is currently standard practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
The best score in the QoR15 (Quality of recovery-15) scale greater than 122
The goal is to evaluate the impact of this accompainment on enhancing the quality of patients anesthetic recovery, as measured by the QoR15 scale
Measured: Within 24 hours followin the surgical procedure
Secondary outcomes (2)
Anxiety in both groups measured using the Beck Anxiety Scale
Anxiety will be measured in both groups: the intervetion grup and the control grup. This assessment will occur at two time points
Measured: Before the surgical procedure and 24 hors after the surgical event
Delirium
Delirium will be measured in the two grups at 3 times points post surgery
Measured: 24 hours, day 5 and day 30.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start1 Jul 2024
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized clinical trial design with two groups * One group will have family accompaniment in the recovery area, the other will not * The QoR-15 scale will be used to measure the quality of anesthetic recovery * The randomization was done using the OpenEpi software
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American British Cowdray Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariana Guadalupe García Hernandez, American British Cowdray Medical Center
- Investigators
- Mariana Garcia, investigator, Principal investigator, American British Cowdray Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06435247
- Sponsor's protocol ID
- CMABC-24-18
- Acronym
- AAR
- Status last verified
- Jul 2024
- First submitted
- 24 May 2024
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Accompaniment by Older Adults on Anaesthetic Recovery
- ClinicalTrials.gov ID
- NCT06435247
- Acronym / sponsor ID
- AAR / CMABC-24-18
- Conditions
- Elderly, Anesthesia; Reaction
- Keywords
- ancianos, añadir la calidad de la recuperación anestésica, añadir acompañamiento
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- American British Cowdray Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 30 May 2024 (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.
Summary:
In 2022, Mexico estimated a population of 17,958,707 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized clinical trial design with two groups * One group will have family accompaniment in the recovery area, the other will not * The QoR-15 scale will be used to measure the quality of anesthetic recovery * The randomization was done using the OpenEpi software
| Arm | Type | Receives |
|---|---|---|
| Accompaniment in the recovery area | Experimental | Behavioral: With or without accompaniment in the recovery anaesthetic areaThe first group will have a family member accompany them in the recovery area |
| without accompaniment | No intervention | –The second group will not have accompaniment as is currently standard practice |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- History of diseasses associated with dementia
- Emergency surgery.
- Regional anesthesia or sedation
- Moderate to severe cognitive impairment
- History of smoking or drugs
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 |
|---|---|---|
| With or without accompaniment in the recovery anaesthetic areaone grup will have family accompaniment in the recovery area and the other group will not in both groups the QoR15 scale will be used to measure the quality of anesthetic recovery | Behavioural | Accompaniment in the recovery area |
Primary outcome
The best score in the QoR15 (Quality of recovery-15) scale greater than 122
Time frame: Within 24 hours followin the surgical procedure
The goal is to evaluate the impact of this accompainment on enhancing the quality of patients anesthetic recovery, as measured by the QoR15 scale
2 secondary outcomes
Anxiety in both groups measured using the Beck Anxiety Scale
Time frame: Before the surgical procedure and 24 hors after the surgical event
Delirium
Time frame: 24 hours, day 5 and day 30.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
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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.
Juan Talavera, consultant contact
Mariana Garcia, investigator principal investigator
American British Cowdray Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing With or without accompaniment in the recovery anaesthetic area in people with Elderly and Anesthesia; Reaction, run by American British Cowdray Medical Center at 2 sites in Mexico.
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 0 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: status not confirmed, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Mexico. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mariana Garcia, investigator (+525541922325, mariana.26_11@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The best score in the QoR15 (Quality of recovery-15) scale greater than 122 (time frame: Within 24 hours followin the surgical procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Aug 2024.